DEPARTMENT OF HEALTH AND HUMAN SERVICES 
 

CENTERS FOR DISEASE CONTROL AND PREVENTION
 

Advisory Committee on 

Immunization Practices (ACIP) 

Summary Report
 

February 26, 2015 

Atlanta, Georgia 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Table of Contents Page 

Agenda 3-4 

Acronyms 5-6 

Welcome and Introductions 7-12 

Meningococcal Vaccine 

 Introduction 

 Consideration for Use of Serogroup B Meningococcal (MenB) Vaccines in Persons at Increased Risk 

 Public Comment 

 Proposed Policy Option 

 VFC Vote 

12-35 

Influenza 

 Introduction 

 Preliminary 2014-2015 Vaccine Effectiveness Estimates 

 Update on Live-Attenuated Influenza Vaccine (LAIV) 

 Proposed Recommendations 

35-44 

Human Papillomavirus (HPV) Vaccines 

 Introduction 

 Summary of 9vHPV Clinical Trial Data and GRADE 

 Overview of Cost-Effectiveness 

 Proposed Recommendations for Use of 9vHPV Vaccine 

 VFC Vote 

44-57 

Yellow Fever Vaccine 

 Introduction 

 Summary of GRADE for Yellow Fever Vaccine Booster Doses 

 Consideration of Booster Doses in Specific Populations 

 Proposed Recommendations for Yellow Fever Vaccine Booster Dose 

57-63 

Public Comment Day 1 63 

Certification 64 

Membership Roster 65-73 

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PRESIDER/PRESENTER(s) 

 Thursday, February 26th 

10:30 Welcome & 

Introductions 

 

 

 

 11:45 Human Papillomavirus (HPV)

Vaccines 

· Introduction 

· Summary of 9vHPV clinical trial data 

and GRADE 

· Overview of cost effectiveness 

· Proposed recommendations for use 

of 9vHPV vaccine 

· VFC vote 

 12:15
 Yellow Fever Vaccine 

· Introduction 

Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) 

Centers for Disease Control and Prevention
 

1600 Clifton Road, NE, Tom Harkin Global Communications Center, Kent "Oz" Nelson Auditorium
 

Atlanta, Georgia 30333
 

February 26, 2015
 

AGENDA ITEM 

10:45 Meningococcal Vaccines 

· 

Introduction 

· Considerations for use of serogroup 

B meningococcal (MenB) vaccines in 

persons at increased risk 

· Public 

comment 

· Proposed policy option 

· VFC Vote 

11:15 Influenza 

· Introduction 

· Preliminary 2014-15 vaccine 

effectiveness estimates 

· Update on Live Attenuated Influenza 

Vaccine (LAIV) 

· Proposed recommendations 

PURPOSE

Information 

& 

Discussion 

Vote 

VFC Vote 

Information 

& 

Discussion 

Vote 

Information 

& 

Discussion 

Vote 

VFC Vote 

Information 

Dr. Jonathan Temte (ACIP
 

Chair)
 

Dr. Larry Pickering (ACIP
 

Executive Secretary; CDC)
 

Dr. Lorry Rubin (ACIP, WG
 

Chair)
 

Ms. Jessica MacNeil
 

(CDC/NCIRD)
 

Ms. Jessica MacNeil 

(CDC/NCIRD)
 

Dr. Jeanne Santoli
 

(CDC/NCIRD)
 

Dr. Ruth Karron (ACIP, WG
 

Chair)
 

Dr. Brendan Flannery
 

(CDC/NCIRD)
 

Dr. Kathleen Coelingh
 

(MedImmune)
 

Dr. Lisa Grohskopf
 

(CDC/NCIRD)
 

Dr. Joseph Bocchini (ACIP, WG
 

Chair)
 

Dr. Emiko Petrosky
 

(CDC/NCHHSTP)
 

Dr. Harrell Chesson
 

(CDC/NCHHSTP)
 

Dr. Lauri Markowitz
 

(CDC/NCHHSTP)
 

Dr. Jeanne Santoli
 

(CDC/NCIRD)
 

Dr. Joseph Bocchini (ACIP, WG
 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

& 

Discussion 
 

Chair) 

· Summary of GRADE for yellow fever 

vaccine booster doses
 

· Consideration of booster doses in 

specific populations
 

· Proposed recommendations for 

yellow fever vaccine booster dose
 

Dr. Erin Staples (CDC/NCEZID) 

Vote
 

12:45 Public Comment 

1:00 Adjourn 

Acronyms 

Centers for Disease Control & CDC Prevention 

GRADE Grading of Recommendations Assessment, Development and Evaluation 

NCHHSTP National Center for HIV, Hepatitis, STD and TB Prevention [of CDC/OID] 

CDC National Center for Immunization & Respiratory Diseases [of NCIRD CDC/OID] 

NCEZID National Center for Emerging and Zoonotic Diseases [of CDC/OID] 

VFC Vaccines for Children 

WG Work Group 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Acronyms Used in This Document 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ABCs Active Bacterial Core Surveillance 

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACNM American College of Nurse Midwives 

AE Adverse Events 

AFP American Family Physicians 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans 

aHUS Atypical Hemolytic Uremic Syndrome 

ASTHO Association of State and Territorial Health Officials 

BLA Biologics License Application 

CDC Centers for Disease Control and Prevention 

CIN Cervical Intraepithelial Neoplasia 

COI Conflict of Interest 

COID Committee on Infectious Disease, AAP 

DHS Department of Homeland Security 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

FDA Food and Drug Administration 

FLU VE Influenza Vaccine Effectiveness Network 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

Hib Haemophilus influenzae Type b 

HIV Human Immunodeficiency Virus 

HPV Human Papillomavirus 

IDSA Infectious Disease Society of America 

IHR International Health Regulations 

IHS Indian Health Service 

IIV Inactivated Influenza Vaccine 

ILI Influenza-Like Illness 

ILINet Influenza-Like Illness Surveillance Network 

IND Investigational New Drug 

ITSU Immunization Technical Support Unit, Public Health Foundation of India 

JE Japanese Encephalitis 

LAIV Live Attenuated Influenza Vaccine 

MCV4 Meningococcal Conjugate Vaccine 

MenACWY Quadrivalent Meningococcal Conjugate Vaccine 

MenB Serogroup B Meningococcal Disease 

MMR Measles, Mumps, Rubella 

MMWR Morbidity and Mortality Weekly Report 

MSM Men Who Have Sex With Men 

NACI National Advisory Committee on Immunization, Canada 

NTAGI National Technical Advisory Group on Immunization, India 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

NCIRD National Center for Immunization and Respiratory Diseases (of CDC/CCID) 

NITAG National Immunization Technical Advisory Group, Peru 

NMA National Meningitis Association 

PAHO Pan American Health Organization 

PCR Polymerase Chain Reaction 

PNH Paroxysmal Nocturnal Hemoglobinuria 

PHFI Public Health Foundation of India 

PIDS Pediatric Infectious Diseases Society 

QALYs Quality Adjusted Life Years 

RCT Randomized Controlled Trial 

SAEs Serious Adverse Events 

SAGE Strategic Advisory Group of Experts (WHO) 

SAHM Society for Adolescent Health and Medicine 

Tdap Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis 

UK United Kingdom 

US United States 

VAERS Vaccine Adverse Event Reporting System 

VE Vaccine Effectiveness 

VFC Vaccines for Children 

VSD Vaccine Safety Datalink 

WG Work Group 

WHA World Health Assembly 

WHO World Health Organization 

WVU West Virginia University 

YF Yellow Fever 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Welcome and Introductions 

Dr. Jonathan Temte 

ACIP Chair 

Dr. Larry Pickering 

Executive Secretary, ACIP / CDC 

Following Dr. Temte’s greeting and call to order, Dr. Pickering welcomed everyone to the 

February 2015 Advisory Committee on Immunization Practices (ACIP) meeting. He expressed 

appreciation for everyone’s understanding about the CDC closure and the necessary 

cancellation of the first day of the meeting due to the inclement weather. He indicated that the 

proceedings of this meeting would be available to people not in attendance via the World Wide 

Web, and welcomed those who could not attend the meeting in person. He then recognized 

Stephanie Thomas and Natalie Greene who were to be present throughout the duration of the 

meeting to assist with various meeting functions. 

Emphasizing that there would be a crowded agenda for the day, Dr. Pickering noted that 

handouts of presentations were distributed to the ACIP members and were made available for 

others on the tables outside of the auditorium. Slides presented during this meeting will be 

posted on the ACIP website approximately two weeks after the meeting concludes, the live 

webcast will be posted within four weeks following the meeting, and the meeting minutes will be 

available on the website within 90 days following this meeting. Meeting minutes are posted on 

the ACIP website generally within 90 days of ACIP meetings. Members of the press interested 

in conducting interviews with ACIP members were instructed to contact Michael Sennett, Joey 

Smith, or KD Hoskins for assistance in arranging interviews. 

Dr. Pickering welcomed the following international guests in attendance: 

 Nearly every meeting, a delegation attends from a member country of the World Health 

Organization’s (WHO’s) Pan-American Health Organization (PAHO). Members of Peru’s 

National Immunization Technical Advisory Group (NITAG) attended this meeting, led by Dr. 

Robert Espinozo, NITAG Chair. With Dr. Espinozo were Dr. Washington Toledo, National 

Immunization Program Manager; and Dr. Abel Salinas and Ms. Lourdes Castillo, NITAG 

members. 

 Seven members of India’s National Technical Advisory Group on Immunization (NTAGI), led 

by Dr. Gangadeep Kang; and three members of the NTAGI secretariat, led by Dr. Inamdar 

were present. Dr. Kang is a Professor in the Department of Gastrointestinal Sciences at the 

Christian Medical College in Vellore, India and is a member of India’s NTAGI. Dr. Inamdar 

is the Senior Advisor for Evidence to Policy at the Immunization Technical Support Unit 

(ITSU) in the Public Health Foundation of India (PHFI), and is a member of the NTAGI 

Secretariat. 

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As a reminder for future international visitors to ACIP meetings, due to changes in Department 

of Homeland Security (DHS) Policy, additional forms will be required for each meeting at the 

time an international guest registers. It is critical that international visitors complete and submit 

these forms as soon as possible following registration. Stephanie Thomas, Committee 

Management Specialist, will be able to help with any questions and concerns about the process

The next ACIP meeting will convene at CDC on Wednesday and Thursday, June 24-25, 2015. 

Registration for all meeting attendees is required and will be open Friday, February 27. 2015. 

The registration deadline for United States (US) citizens is Wednesday, June 10th, and for nonUS citizens is Wednesday, June 3rd. Registration is not required for webcast viewing. 

 

 

 

 

 

 

Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

 The following three long-time friends were in attendance from Japan: 

 Dr. Mitsuaki Hosoya, Chair and Professor of Pediatrics at Fukushima Medical 

University in Fukushima, Japan 

 Dr. Nobuhiko Okabe, Director General of Kawasaki City Institute for Public Health in 

Japan. 

 Dr. Hajime Kamiya, Medical Officer, National Institutes of Infectious Diseases in 

Tokyo, Japan. 

. 

Notes regarding members and liaison representatives included the following: 

Ex Officio Members 

 Jeff McCollum attended this meeting on behalf of Amy Groom, representing the Indian 

Health Service (IHS). 

 Dr. Eric Sergienko is the new ex officio member representing the Department of Defense 

(DoD). 

Liaisons 

 Dr. Caroline Quach attended on behalf of Dr. Ian Gemmill, representing the Canadian 

National Advisory Committee on Immunization (NACI). 

 Dr. Kimberly Martin attended on behalf of Dr. Terry Dwelle, representing the Association of 

State and Territorial Health Officials (ASTHO). 

 ACIP welcomed the American College of Nurse Midwives (ACNM) as a new liaison 

organization, and Carol Hayes as their representative. ACNM is one of four professional 

organizations that works with CDC in preparation of the yearly adult immunization schedule. 

 Dr. Carrie Byington, representative of the American Academy of Pediatrics (AAP) was 

appointed Chair of AAP’s Committee on Infectious Diseases (COID) on July 1, 2014. 

 Dr. Ken Schmader, American Geriatric Society (AGS), attended via teleconference. 

To avoid disruptions during the meeting, Dr. Pickering requested that those present turn off all 

cell phones. He explained that topics presented during the ACIP meeting include open 

discussion with time reserved for public comment. During this meeting, a time for public 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

comment was scheduled following the afternoon sessions during both meeting days. Time for 

public comments also may be provided prior to specific votes by ACIP to enable these 

comments to be considered before any votes. Those who planned to make public comments 

were instructed to visit the registration desk in the rear of the auditorium to have Stephanie 

Thomas record their name and provide information about the process. Those who registered to 

make public comments were instructed to state their name, organization if applicable, and any 

conflicts of interest (COIs) prior to making their comments. 

Safety issues will continue to be presented during every ACIP meeting. During this meeting, 

these issues were included as part of specific topic presentations. 

With regard to disclosure, to summarize conflict of interest provisions applicable to ACIP, as 

noted in the ACIP Policies and Procedures manual, Dr. Pickering indicated that members of the 

ACIP agree to forego participation in certain activities related to vaccines during their tenure on 

the committee. For certain other interests that potentially enhance a member’s expertise while 

serving on the committee, CDC has issued limited conflict of interest waivers. Members who 

conduct vaccine clinical trials or who serve on data safety monitoring boards (DSMBs) may 

present to the committee on matters related to those specific vaccines. However, they are 

prohibited from participating in committee votes on issues related to those specific vaccines. 

Regarding other vaccines of the affected company, a member may participate in a discussion 

with a proviso that he or she abstains on all votes related to the vaccines of that company. It is 

important to note that at each meeting, ACIP members state any conflicts of interest. 

Applications for ACIP membership are due no later than November 13, 2015 for the 4-year term 

beginning July 2016. Detailed instructions for submission of names of potential candidates to 

serve as ACIP members may be found on the ACIP web site: 

E-mail: acip@cdc.gov Web homepage: http://www.cdc.gov/vaccines/acip/index.html 

Nominations: http://www.cdc.gov/vaccines/acip/committee/req-nominate.html 

A current CV, at least one recommendation letter from a non-federal government employee, and 

complete contact information are required. These may be submitted as e-mail attachments to 

Stephanie Thomas at hkp4@cdc.gov 

During every ACIP meeting, an update is provided with regard to the status of ACIP 

recommendations. There have been two publications since October 2014: the Child 

Adolescent Immunization Schedule and the Adult Immunization Schedule. In addition, “ACIP 

Recommendations on the Use of Typhoid Vaccines” are projected to be published in the 

MMWR on March 27, 2015. 

Recommendations and immunization schedules can be downloaded from the ACIP website. 

ACIP has a policy that every three to five years, each recommendation is reviewed and then 

renewed, revised, or retired. 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

The following resource information pertaining to ACIP is available on the CDC website: 

Vaccine Safety: 

www.cdc.gov/vaccinesafety/index.html 

Immunization Schedules (2014):

http://www.cdc.gov/vaccines/schedules/index.html 

Vaccine Toolkit: 

http://www.cdc.gov/vaccines/hcp/patient-ed/conversations/index.html 

Immunization for Women (American College of Obstetricians and Gynecologists):

www.immunizationforwomen.org 

You Are the Key to HPV Cancer Prevention:

http://www.cdc.gov/vaccines/youarethekey 

Vaccines for Preteens and Teens: 

http://www.cdc.gov/vaccines/who/teens/index.html 

Before officially beginning the meeting, Dr. Temte called the roll to determine whether any ACIP 

members had conflicts of interest. The following conflicts of interest were declared: 

 Belongia: Receives research funding from MedImmune and has a conflict on influenza 

vaccines 

 Bennett, Bocchini, Campos-Outcalt, Harrison, Harriman, Karron, Kempe, Pellegrini, 

Reingold, Riley, Romero, Rubin, Temte, and Vazquez: No conflicts 

Dr. Temte then acknowledged Dr. Pickering’s many years of service. He said that he had the 

pleasure of first meeting Dr. Pickering when they were both involved in the March 2000 CDC 

Measles Elimination Meeting convened in Atlanta. Over those years, he noticed the number of 

people who were in attendance at that meeting who have also been present at ACIP meetings. 

Dr. Temte noted that they also had the great pleasure of having Dr. Pickering’s wife, Mimi, and 

daughter, Maggie, in attendance during this meeting. His son, Andrew, was unable to attend 

due to a scheduling conflict. Dr. Temte recounted that everyone sitting around the table had 

benefitted from the hospitality of the Pickerings, who have often hosted some of the ACIP 

members for a respite and wonderful home-cooked meal. 

As the Executive Secretary of ACIP, Dr. Pickering has overseen more than 25 ACIP meetings. 

He has brought uniformity in presentations and enhanced the level of all of the work being done 

by the committee, including high quality products. He has conducted meetings through 

outbreaks, a pandemic, a government shutdown, and now during a Southern snowstorm. He 

has shepherded over 50 ACIP-related MMWR articles, including articles on universal influenza 

vaccination and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) 

administration during pregnancy. He was instrumental in the adoption of the Grading of 

Recommendation Assessment, Development and Evaluation (GRADE) Methodology in 2010; 

has been an eloquent spokesperson for vaccines and CDC’s immunization policies and 

recommendations; and has graced everyone with his expertise, experience level, sensibilities, 

sensitivities, wisdom, and leadership over the last 9 years. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

In conclusion, Dr. Temte said, “It’s a magical world, Larry ol’ buddy. We just want to give you 

our thanks and appreciation for your many endeavors to keep it a magical world for millions of 

children and adults.” 

Meningococcal Vaccines 

Introduction 

Lorry Rubin, MD

Chair, Meningococcal Work Group 

Advisory Committee on Immunization Practices 

Dr. Rubin expressed his gratitude to Dr. Pickering for all of his contributions. He indicated that 

in the interest of time, this session would include a discussion of and vote on the meningococcal 

B vaccine for high-risk individuals. Discussion of the broader use of meningitis B vaccines for 

adolescents will be deferred until the June 2015 meeting. 

Considerations for use of Serogroup B Meningococcal

(MenB) Vaccines in Persons at Increased Risk 

Jessica MacNeil, MPH 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

For use of serogroup B meningococcal (MenB) vaccines in persons at increased risk, Ms. 

MacNeil summarized current meningococcal vaccination recommendations for persons at 

increased risk, reviewed the groups at increased risk for serogroup B meningococcal disease, 

reviewed immunogenicity and safety data for the MenB vaccines, summarized the outcomes 

from the GRADE evaluation, and presented proposed policy option language for a vote. 

Meningococcal conjugate vaccines are routinely recommended for persons ≥2 months of age at 

increased risk for meningococcal disease, including persons with persistent complement 

component deficiencies, persons with anatomic or functional asplenia, microbiologists who are 

exposed routinely to isolates of Neisseria meningitidis, persons at risk during a community 

outbreak attributable to a vaccine serogroup, persons who travel to or reside in countries in 

which meningococcal disease is hyperendemic or epidemic, unvaccinated or incompletely 

vaccinated first-year college students living in residence halls, and military recruits. 

There are now two serogroup B meningococcal vaccines licensed in the US for use in persons 

10 through 25 years of age. Trumenba® is a three-dose series and was licensed by the Food 

and Drug Administration (FDA) in October 2014. Bexsero® is a two-dose series and was 

licensed by the FDA in January 2015. Bexsero® was also licensed in several other countries for 

use in persons ≥2 months of age. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

The work group (WG) has been discussing a number of different options for use of MenB 

vaccines. To address the immediate need of protecting groups at increased risk, the WG 

suggested language for vaccination of persons with persistent complement component 

deficiencies, persons with anatomic or functional asplenia, microbiologists who are routinely 

exposed to isolates of Neisseria meningitidis, and persons identified to be at increased risk 

because of a serogroup B meningococcal disease outbreak. The WG also has been reviewing 

available data and discussing options for broader use of MenB vaccines in adolescents and 

college students. Policy options for broader use of MenB vaccines will be discussed during a 

future meeting. 

The WG has discussed a number of age-group options for recommendations for persons at 

increased risk, including the current licensed age indication for both MenB vaccines, which 

includes persons 10 through 25 years of age. Additionally, the WG considered language for 

persons aged ≥2 months at increased risk as Bexsero® is currently licensed for persons over 

age two months in other countries. However, data are not currently available for use of 

Trumenba® in children less than 10 years of age. The schedule and reactogenicity profile for 

MenB vaccines are quite different in young children compared to adolescents. The WG plans to 

review the data for persons aged 2 months through 10 years, and may propose extended policy 

options for persons at increased risk in the future. During this session, the WG suggested 

language for use of MenB vaccines in persons 10 years of age and older who are at increased 

risk for meningococcal disease. This extends beyond the licensed age indication, but the WG is 

comfortable that there are no theoretical differences in safety for those >25 years as compared 

to those 10 through 25 years of age. 

Regarding the groups at increased risk for serogroup B meningococcal disease, persistent or 

genetic deficiencies in the complement pathway are well-known to increase risk for 

meningococcal disease. These deficiencies are rare and only affect about 0.03%1 of the US 

population. Individuals with persistent complement component deficiencies are at up to a 

10,000-fold2 increased risk for developing meningococcal disease and often develop recurrent 

infection [1

P Densen. Complement deficiencies and meningococcal disease. Clin Exp Immunol. 

Oct 1991; 86(Suppl 1): 57-62; 2

Cohn et al. Prevention and Control of Meningococcal Disease. 

MMWR. March 22, 2013; 62 (RR-2)]. 

Eculizumab (Soliris®) is a monoclonal antibody that is approved for treatment of atypical 

hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). It 

functionally creates a complement deficiency by binding to C5 and inhibiting the terminal portion 

of the complement cascade. Several individuals (n=5/326) in the clinical trials for eculizumab 

have reportedly developed meningococcal infections despite prior vaccination with conjugate 

vaccines. Persons being treated with eculizumab were not explicitly included in the conjugate 

vaccine recommendations; however, meningococcal vaccination is required for persons prior to 

treatment [http://soliris.net/sites/default/files/assets/soliris_pi.pdf]. 

Persons with functional or anatomic asplenia also appear to be at increased risk for 

meningococcal disease. However, the data are less compelling than for pneumococcal disease 

risk1

. This group includes sickle cell disease, which affects approximately 90,000 to 100,000 

persons of all ages2 in the US. In asplenic persons, the case-fatality ratio is also elevated for 

meningococcal disease (40% to 70%)3

. It has been demonstrated that people with asplenia 

have a significantly lower response to one dose of meningococcal C (MenC) vaccine4 [

1

Cohn et 

al. Prevention and Control of Meningococcal Disease. MMWR. March 22, 2013; 62 (RR-2);

2

http://www.cdc.gov/ncbddd/sicklecell/data.html; 3Updated recommendations for the use of 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

meningococcal conjugate vaccines. MMWR. January 28,2011; 60(3): 72-76; 4Balmer, P et al. 

Infection and Immunity, Jan 2004, 332-337]. 

Microbiologists who work with Neisseria meningitidis are also at increased risk for 

meningococcal disease. In a review by Sejvar et al (2005), 16 cases were reported worldwide 

between 1985 and 2001. All occurred among clinical microbiologists in medical microbiology 

laboratories, with 7 cases due to serogroup C and 9 due to serogroup B. None of the cases in 

the review occurred in persons working in hematology, chemistry, or research laboratories. Of 

the 16 cases, 8 (50%) were fatal, and 15 occurred in microbiologists who had performed strain 

manipulation on an open laboratory bench. Since this review, 6 additional cases of 

meningococcal disease have been reported in microbiologists. Of these, 2 occurred in the US 

and 1 each occurred in New Zealand, France, Sweden, and Argentina. These cases included 

cases in industry and research microbiologists [Sejvar et al. Assessing the risk of laboratory 

acquired meningococcal disease. J Clin Microbiol 2005; 43:4811-4. CDC. Laboratory-acquired 

meningococcal disease – United States, 2000. MMWR 2002;51:141-4. Borrow et al. Safe 

laboratory handling of Neisseria meningitidis. J of Infection 2014; 68:305-312]. 

The Sejvar paper estimated an attack rate of 13/100,000 among microbiologists who work with 

Neisseria meningitidis1

. The high case fatality ratio observed among microbiologists who have 

developed meningococcal infection is likely due to exposure to high concentrations of 

organisms and highly virulent strains. The majority of cases have occurred among clinical 

microbiologists who were not using respiratory tract protection at the time of exposure. 

The final group includes persons at risk because of a serogroup B meningococcal disease 

outbreak. Fortunately, meningococcal outbreaks are rare, historically causing only about 2% to 

3% of US cases1

. However, five serogroup B clusters/outbreaks have been reported on college 

campuses during 2009 through 2013. In two of these recent outbreaks, students were 

estimated to be at a 200- to 1400-fold increased risk for meningococcal disease during the 

outbreak period. In the recently published guidance for serogroup B meningococcal outbreaks 

in institutional settings, the thresholds for considering vaccination were defined as 2 cases in 

institutions with populations less than <5,000 persons and 3 cases in institutions with 

populations of ≥5,000 persons2 [

1 National Notifiable Diseases Surveillance 

System2

http://www.cdc.gov/meningococcal/downloads/interim-guidance.pdf]. 

During the first two months of 2015, two outbreaks of serogroup B meningococcal disease were 

reported on college campuses in the US. Two cases occurred among students at a Rhode 

Island college, which has 4500 students. A vaccination campaign was conducted in response 

to the cases using Trumenba®, and approximately 98% of the target population received Dose 

1. Four cases of serogroup B meningococcal disease have been reported at an Oregon 

university with 25,000 students, including one death. Two of the four cases were 

epidemiologically linked, but were not close contacts with one another. Planning is currently 

underway for a MenB mass vaccination campaign scheduled to begin on March 2, 2015. 

Additional sporadic cases of serogroup B meningococcal disease in college students have also 

been reported to the CDC this winter. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

The following table summarizes the risk groups and includes the available data on cases that 

have occurred in each of the risk groups: 

Approximately 300,000 to 350,000 individuals fall into these groups. Although only a handful of 

cases have been documented in Active Bacterial Core surveillance (ABC) or the published 

literature, these groups are well-known to be at increased risk for meningococcal infection and 

are currently recommended to be vaccinated with meningococcal conjugate vaccine, but remain 

at risk for serogroup B meningococcal disease. 

Three groups are included in the current conjugate vaccine recommendations but are not 

proposed to be included for MenB. First-year college students living in residence halls are not 

included because they are being considered in the broader adolescent and college student 

policy options. Travelers are also not being considered because their risk is primarily due to 

serogroups other than B. Military recruits are not being considered because the current MenB 

epidemiology in the military is similar to the US population1 and the Department of Defense 

(DoD) sets its own vaccination policies [1

Broderick M, et al. Incidence of Meningococcal Disease 

in the United States Military Before and After Adoption of the Conjugate Vaccine (MCV-4). EID. 

Feb 2015]. 

In summary of the available immunogenicity and safety data, both of the MenB vaccines have a 

demonstrated immune response in the general adolescent population. Nearly all adolescents in 

clinical trials achieved protective antibody titers after either three doses of Trumenba® or two 

doses of Bexsero®. For Bexsero®, response rates were somewhat lower in a small study 

conducted among US and Polish adolescents. However, it is important to remember that 

immunogenicity data are not directly comparable for Trumenba® and Bexsero® in part because 

the primary endpoints differed for each of the vaccines. Immunogenicity data are not currently 

available from persons in most of the groups at increased risk, although limited data are 

available for use in laboratory workers. Only limited short-term (18 through 23 months) antibody 

persistence data are available for Bexsero®. Persistence data for Trumenba® should be 

forthcoming shortly, which will be important for informing booster recommendations for these 

groups at increased risk in the future. 

Several pieces of additional data are needed for both vaccines to inform policy decisions, 

including immunogenicity against additional strains to evaluate breadth of coverage, antibody 

persistence data, safety and immunogenicity data (concomitant vaccination, groups at 

increased risk, other age groups), and additional safety data. A number of these studies are 

ongoing, and data will be reviewed by the WG when available. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

New data on the safety and immunogenicity of concomitant administration and the safety and 

tolerability of Trumenba® have become available since the October 2014 ACIP meeting. A 

detailed description of the newly available data for Trumenba® was provided to the voting 

members of ACIP. The safety and immunogenicity of concomitant administration of Trumenba® 

with Menactra® and Adacel® were evaluated. The local and systemic reactogenicity profiles 

were demonstrated to be similar when Trumenba® was administered alone or concomitantly 

with the other vaccines. In addition, non-inferior immune responses to all Tdap and MenACWY 

antigens and the MenB test strains were observed. 

In a large-scale safety study which evaluated the safety and tolerability of Trumenba®

, the 

safety profile observed was consistent with studies that supported licensure. There are limited 

plans for both manufacturers to collect immunogenicity data from persons in the groups at 

increased risk. A small immunogenicity study is currently underway for 150 persons 2 through 

17 years of age with complement component deficiencies and asplenia receiving two doses of 

Bexsero®. Data from this study are anticipated to be available in 2016. In addition, small 

studies are currently ongoing for both Trumenba® and Bexsero® in laboratory workers. 

In summary of safety, MenB vaccines are more reactogenic than other vaccines given during 

adolescence. However, the majority of local and systemic reactions to the MenB vaccines are 

mild to moderate in severity and are transient, with the most common adverse event (AE) 

reported being pain at the injection site. Serious adverse reactions (SAEs) are rare, and rates 

are similar between vaccine recipients and controls in the clinical trials. Safety data specific to 

the groups at increased risk are not currently available, but are anticipated to be similar to the 

general population. 

In terms of other sources of safety data for MenB vaccines, there is limited experience outside 

of clinical trials. Most of this experience is with Bexsero®, which has been administered to 

approximately 17,000 persons vaccinated under an expanded access Investigational New Drug 

(IND) program for outbreak response at two US universities and in over 40,000 persons 

vaccinated in a regional public health program in Québec. No concerning patterns were 

observed among AEs following any of the vaccination programs. For Trumenba®, no postlicensure safety data are currently available, but it is CDC’s understanding that safety data are 

being collected for Trumenba® in conjunction with the two current outbreak responses in Rhode 

Island and Oregon. 

The WG also reviewed data on theoretical concerns from mouse models about the potential for 

development of autoimmune disorders following MenB vaccination. The FDA also reviewed 

these data, and did not observe any differences in the rate of autoimmune disorders between 

vaccine recipients and controls in the safety studies that supported licensure. Post-licensure 

safety surveillance will be conducted to detect potential safety signals. However, a large 

number of doses must be administered to detect any potential safety signals in the Vaccine 

Safety Datalink (VSD). In the meantime, passive reports to the Vaccine Adverse Event 

Reporting System (VAERS) will be monitored. 

In summary of the GRADE evaluation outcomes, as a reminder, the first step in the GRADE 

process is to formulate the study questions. The following initial study questions were agreed 

upon by the Meningococcal WG, although Ms. MacNeil focused only on the last two during this 

session: 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Questions Population 

1. Should MenB vaccine be 

administered routinely to all 

adolescents and young adults? 

Adolescents and young adults 10 through 25 

years of age 

2. Should MenB vaccine be 

administered to college 

students to prevent outbreaks? 

College students 15 through 25 years of age 

3. Should MenB vaccine be 

administered to persons at 

increased risk for serogroup B 

meningococcal disease? 

Microbiologists, persons with persistent 

complement component deficiencies or 

functional or anatomic asplenia (including 

sickle cell anemia) 

4. Should MenB vaccine be 

administered during outbreaks? 

Individuals at increased risk for serogroup B 

disease because of an outbreak 

The outcomes that were ranked as critical for each question by the Meningococcal WG included 

the following: 

 Burden of disease 

 Mortality of disease 

 Long-term sequelae 

 Serogroup B strain coverage 

 Short-term immunogenicity 

 Persistence of immunogenicity (1 to 2 years after vaccination) 

 Serious adverse events 

The first four outcomes cannot be assessed in GRADE because they are surveillance data. 

These outcomes were evaluated using a modified assessment, and the last three outcomes 

were assessed using GRADE. In GRADE, all of the available data for each outcome are 

evaluated on the following six criteria to determine whether the overall evidence type is moved 

up or down and a final evidence type is assigned: 

 Risk of bias (methodological limitations) 

 Inconsistency 

 Indirectness 

 Imprecision 

 Publication bias 

 Other considerations (strength of association, dose gradient, direction of all plausible 

residual confounding) 

Given the time constraints during this meeting, Ms. MacNeil reviewed only the available data 

that were used to assess the benefits and harms for each vaccine, and the final evidence type 

assigned to each MenB vaccine for use in persons at increased risk and in outbreak settings. A 

copy of the full presentation for the GRADE evaluation was provided in the ACIP members’ 

binders. 

For Bexsero®, a total of six studies were reviewed, including two open-label studies and four 

randomized-control trials. The majority of the studies assessed several outcomes. Four of the 

studies have been published. However, data were also used from additional unpublished 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

studies. In addition, safety data from three vaccination campaigns were reviewed for SAEs. 

For Trumenba®, a total of eight studies were reviewed, including three open-label studies and 

six randomized-control trials. The majority of the studies assessed several outcomes. Results 

of three of the studies have been published. However, additional unpublished data were also 

used. Antibody persistence data are not yet available for Trumenba®, so they were not 

assessed in this evaluation. 

The overall evidence type for use of Bexsero® among persons at increased risk for serogroup B 

meningococcal disease was graded as Type 3, and among outbreak at risk populations as Type 

2. The overall evidence type for use of Trumenba® among persons at increased risk for 

serogroup B meningococcal disease was graded as Type 3, and among outbreak at risk 

populations as Type 2. Based on the available data and evidence reviewed, the WG supports 

routine vaccination of persons at increased risk for meningococcal disease for several reasons, 

including the demonstrated disease risk in the specific risk groups and that these groups are 

currently recommended to be vaccinated with MenACWY conjugate vaccines. Additionally, 

there is a demonstrated immune response to MenB vaccines in the general adolescent 

population and there are no theoretical safety concerns for persons >25 years of age from 

vaccination as compared to persons aged 10 through 25 years. 

The WG also supports harmonization of the current MenACWY conjugate vaccine 

recommendations with the proposed MenB language in two areas where the language differs. 

First, use of eculizumab (Soliris®) will be explicitly included as an indication for vaccination with 

MenACWY conjugate vaccine. Secondly, the wording for the use in outbreaks will be aligned 

with the proposed wording for MenB vaccines to read, “Persons identified to be at increased risk 

because of a meningococcal disease outbreak attributable to serogroups A, C, W, or Y.” The 

two sets of recommendations would still differ for certain special populations (e.g., travelers, 

first-year students living in residence halls, and military recruits) who are not included in the 

proposed MenB language. 

The WG’s proposed language for use of MenB vaccines for persons at increased risk was as 

follows: 

A serogroup B meningococcal (MenB) vaccine series should be administered to persons 

aged ≥10 years at increased risk for meningococcal disease. (Category A) This includes: 

 Persons with persistent complement component deficiencies1 

 Persons with anatomic or functional asplenia2 

 Microbiologists routinely exposed to isolates of Neisseria meningitides 

 Persons identified to be at increased risk because of a serogroup B meningococcal 

disease outbreak 

1

Including inherited or chronic deficiencies in C3, C5-9, properdin, factor D, factor H, or 

taking eculizumab (Soliris®)

2

Including sickle cell disease 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

In addition, the following guidance for use was proposed: 

 Depending on the MenB product used, a complete two- or three-dose series of vaccine 

is required for protection from serogroup B meningococcal disease. 

 The same vaccine product should be used for all doses. 

 No product preference is to be stated. 

In conclusion, Ms. MacNeil thanked the members of the ACIP Meningococcal WG for the 

dedication and thoughtful discussions over the last several months as they quickly worked 

through a review of the available evidence for these new MenB vaccines. 

Discussion Points 

Regarding the differences between the quadrivalent MenACWY and the B vaccine and 

recognizing that the military sets its own vaccination policy, Dr. Reingold asked whether it was 

generally envisioned that differences between use of the B vaccine and use of the quadrivalent 

in terms of travelers and college students would remain differences in terms of how the two 

vaccines are used. 

Ms. MacNeil responded that the differences would remain. The plan is to consider adolescents 

and college students in June 2015 as part of the broader recommendations. But, the 

differences for travelers and the military would remain. 

Dr. Harriman asked whether the WG would also consider the use of B and MenACWY 

meningococcal vaccines for infants, noting that the Affordable Care Act (ACA) requires that 

Category A and B recommendations be covered. 

Dr. Rubin replied that the WG intends to consider MenACWY use in infants during future 

deliberations. 

Dr. Sawyer (PIDS) requested clarification regarding why the use for high risk begins at age 10 

as opposed to a younger age, given that one of the vaccines is licensed for use in children 

younger than 10 years of age. 

Ms. MacNeil indicated that currently in the US, the minimum licensure age is 10. Bexsero® is 

licensed down to two months of age in other countries. The WG will eventually review this 

issue. For this vote, they only wanted to propose the recommendation for 10 years of age and 

older. 

Dr. Harrison asked what is being done specifically to monitor safety in the context of these 

vaccines during outbreaks, and what the DoD’s protocol is in terms of using these two vaccines. 

Ms. MacNeil replied that when the vaccine was used under an IND, as part of the IND, a 

specific safety follow-up was done. Her understanding is that this is also being done for 

Trumenba® in the two current outbreaks, although CDC is not involved in those investigations. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Sergienko (DoD) responded that MenACWY vaccine is currently being administered. The 

Joint Preventive Medicine Working Group met last month to discuss MenB vaccine, and they do 

not think there is an indication for administering that in the recruit population at this point. 

Dr. Duchin (NACCHO) asked whether the threshold for vaccination for use of the MenB vaccine 

as currently stated for the IND would remain the same for the vaccine if a vote was taken to 

approve the use of that vaccine in outbreak settings. He also inquired about what is known 

regarding the impact of the vaccine on carriage. 

Ms. MacNeil responded that the thresholds for the use of MenB vaccines in institutional settings 

under an IND are being used for the current outbreak, which will likely continue in the near-term. 

There are plans to review the entire outbreak guidelines and present results during the October 

2015 or February 2016 ACIP meeting. While little is known about carriage, carriage studies will 

begin at the universities currently experiencing outbreaks. Hopefully, there will be more data 

regarding carriage available by the June or October 2015 ACIP meeting. 

In the spirit of full disclosure, Dr. Temte emphasized that recommendations for a universal 

vaccination would be discussed during the June 2015 ACIP meeting. 

Public Comments: High Risk MenB Recommendations 

Dr. Mary Ferris

Student Health Director 

University of California Santa Barbara 

We have a campus of 30,000 students, faculty, and staff. In November 2013, our campus 

community was devastated by an outbreak of four cases of meningococcal serogroup B disease 

within a 10-day period. It resulted in life-threatening complications to our first case of a 19 year 

old lacrosse team member who suffered amputations to both legs and has extensive skin grafts 

and scarring, but did survive. So, I know you’re aware of the devastating consequences of this 

terrible disease. But, you may not know the impact it has on a university when an outbreak 

occurs. National news outlets camped out on the campus. There was widespread fear and 

even panic among the students, faculty, staff, and the surrounding city. The local school district 

initially prohibited our student teachers from their sites. Parents drove in to take their children 

back home. Our campus childcare center refused to have the student volunteers there. 

Parents demanded we close the campus, but did not want their students to come home for the 

Thanksgiving holiday. It was really terrible for all of us, as you can imagine. 

Our local public health department and the CDC helped us and established special phone lines 

to handle the high volume of increasing distress calls. We greatly appreciate all the help they 

gave us. And as you know, we were able to obtain the MenB vaccine through a special FDA 

approval with the assistance of the CDC. But, we would have preferred to avoid this disaster 

completely by protecting our students in advance with a vaccine that covers MenB. So, we’re 

glad to have your approval of the vaccine for outbreak settings, but we think that we would 

benefit even more if our students came to campus already protected by the vaccine. Outbreaks 

will happen again, and as you are hearing, it’s currently going on at the University of Oregon, 

and they’re struggling to find a source to pay for those vaccines. Even one case in a college 

setting has major repercussions on the institution, and most colleges will not have the resources 

to pay for vaccines when these outbreaks occur. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

We need the ACIP to establish MenB vaccine as part of routine adolescent immunizations so 

that our entering students can be protected before they arrive on campus and are exposed to 

meningococcus, not just after an outbreak occurs. We also can benefit from your 

recommendation for pre-entry vaccination so that we can enforce that in our entry immunization 

requirement before students even get to campus. The majority of our students are firstgeneration college students, coming from low-income families, and do not have the ability to 

afford this vaccine unless it’s covered by health insurance, which, as you know, follows your 

recommendations. Thank you for allowing me to speak. I sincerely hope you’ll consider the 

impact of this disease on both the individuals and our colleges and universities when you make 

your decision. 

Seth Ginsberg 

Co-Founder / President

Global Healthy Living Foundation (GHLF) 

I have no disclosures to make today. GHLF receives funding through grants and partnerships 

with industry, private foundations, as well as the government. I’m here today on behalf of Dr. 

Neal Raisman, who was here down from Columbus yesterday and, unfortunately, needed to 

return to an urgent issue back at home. So, instead I’ll read his brief comments here, and I will 

not attempt his Boston accent. 

My name is Neal Raisman. In 2005, I was the father of two. Today, I am the father of 

one. On the morning of September 27th, my youngest son, Isaac, woke with a 

headache and was dead of meningococcal by 4:30 the same day. I found his body. He 

had less than 12 hours from the time he told us he had a headache until he died, and a 

vaccine would have prevented his death. It’s an epidemiological story you all know too 

well, but it's a personal story I never wanted to know. Today I’m here as a spokesperson 

for the Global Healthy Living Foundation, and together we are asking this committee to 

endorse the FDA labeling recommendation, which is for immunization to prevent 

invasive disease caused by Neisseria meningitidis serogroup B for individuals 10 

through 25 years of age. 

My words here today and your committee meeting could not come at a more immediate 

time. As you know, eight days ago, Lauren Jones, a student at the University of Oregon, 

added her name to the list of those who have died of meningitis. Just three days ago, a 

UC Davis student was diagnosed with meningitis. At the University of Oregon, students 

who have the money will be able to get the vaccine for meningitis B and those who do 

not will remain exposed to its ravages. 

Since the FDA approved vaccine for meningococcal strain B in November of 2014, 

people have died. Did they die because the ACIP didn’t act? Perhaps. Although the 

vaccine was available to those who could afford to pay for it, without your 

recommendation, as you know, insurance companies and Medicaid won’t cover the cost. 

It’s not difficult to conclude that informed people with the money to pay for the vaccine 

have lived and those who can’t afford it or don’t know about it have died. This is counter 

to everything the ACIP, the CDC, the FDA, and, of course, the NIH stand for. Your 

endorsement vote for the FDA recommendation would realign this committee with its 

mission and with the values and expectations of parents with college-aged children. We 

expect the government to tell us when the health of our children is in danger and then 

help us decide what to do about it. 

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Vote: MenB Vaccines for Persons Aged 

≥10 Years at Increased Risk for Meningococcal Disease 

 0 Opposed: N/A
 

0 Abstained: N/A
 

Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Because meningitis is nearly always fatal, the low numbers of people affected mask the 

toll these cases take on families, such as mine, and on our communities. My job today 

is to help you understand the depth of the emptiness that we parents feel every day and 

the heartache we feel for those parents who are about to join our ranks—the ranks of 

families minus one. Please act so other young people and their families are not so 

violently affected by meningitis. Please act so there are no more Isaacs and Laurens. 

Thank you very much. 

Dr. Susan Even 

ACIP Liaison 

American College Health Association 

I just wanted to speak on behalf of the American College Health Association (ACHA), which is 

very aware of the devastating physical and emotional impact of meningococcal disease on the 

individual college student and their families, and the campus communities in sporadic cases and 

outbreaks, as have been eloquently described. The American College Health Association is 

committed to promoting implementation of CDC’s immunization recommendations on college 

campuses, including pre-matriculation meningococcal conjugate vaccine (MCV4). Now that 

MenB vaccines are licensed and these cases continue to arise, ACHA appreciates being 

involved in the ongoing discussion regarding use in outbreaks, appreciates the impact that this 

guidance will have in promptly responding to this challenging situation, and also supports 

prompt deliberations and an expeditious decision regarding the general recommendations for 

MenB vaccine so information will be available to parents, families, students, and campuses for 

the students entering in the fall of 2015. Thanks. 

Dr. Romero made a motion to approve the MenB vaccines recommendation for persons aged 

≥10 years at increased risk for meningococcal disease. Dr. Kempe seconded the motion. The 

motion carried with 15 affirmative votes, 0 negative votes, and 0 abstentions. The disposition of 

the vote was as follows: 

15 Favored: Bennett, Belongia, Bocchini, Campos-Outcalt, Harriman, Harrison, Karron, 

Kempe, Pellegrini, Romero, Reingold, Riley, Rubin, Temte, and Vazquez
 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Vaccines for Children 

Dr. Jeanne M. Santoli 

Immunization Services Division 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention 

Dr. Santoli explained that the purpose of this revision was to update the resolution to: (1) clarify 

eligible groups for meningococcal conjugate vaccines; (2) streamline the schedule and interval 

information for meningococcal conjugate vaccines by incorporating links to published 

documents; and (3) add meningococcal serogroup B vaccines recently licensed for use. The 

following minor clarifications in language were proposed (changes were shown in yellow in the 

presentation, but are underlined in this document): 

Meningococcal Conjugate Vaccines (MenACWY and HibMenCY) 

Eligible Groups: 

 Children aged 2 months through 10 years who are at increased risk for meningococcal 

disease attributable to serogroups A, C, W, and Y, including: 

Children who have persistent complement component deficiencies (including 

inherited or chronic deficiencies in C3, C5-C9, properdin, factor H, or factor D or 

taking eculizumab [Soliris®]) 

Children who have anatomic or functional asplenia, including sickle cell disease 

Children traveling to or residing in countries in which meningococcal disease is 

hyperendemic or epidemic, particularly if contact with local population will be 

prolonged 

Children identified to be at increased risk because of a meningococcal disease 

outbreak attributable to serogroups A, C, W, or Y 

 All children aged 11 through 18 years 

Recommended Vaccination Schedule and Intervals: 

Recommended schedules and intervals for meningococcal conjugate vaccines can be 

found at the following links: 

http://www.cdc.gov/mmwr/pdf/rr/rr6202.pdf 

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6324a2.htm 

Recommended Dosage: 

Refer to product package inserts. 

Contraindications and Precautions 

Contraindications and Precautions can be found in the package inserts available 

at 

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM09 

3833 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Serogroup B Meningococcal Vaccines (MenB) 

Eligible Groups: 

 Children aged 10 through 18 years at increased risk for meningococcal disease 

attributable to serogroup B, including: 

Children who have persistent complement component deficiencies (including 

inherited or chronic deficiencies in C3, C5-C9, properdin, factor H, or factor D 

or taking eculizumab [Soliris®]) 

Children who have anatomic or functional asplenia, including sickle cell 

disease 

Children identified to be at increased risk because of a meningococcal 

disease outbreak attributable to serogroup B 

Recommended Schedule and Intervals: 

Recommended Dosage: 

Refer to product package inserts. 

Contraindications and Precautions: 

Contraindications and Precautions can be found in the package inserts available at 

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM093833 

The following language would appear at the end of the recommendation: 

[If an ACIP recommendation regarding meningococcal vaccination is published within 12 

months following this resolution, the relevant language above (except in the eligible 

groups sections) will be replaced with the language in the recommendation and 

incorporated by reference to the publication URL.] 

Discussion Points 

In terms of eligible groups, Dr. Bocchini requested clarification regarding HibMenCY vaccine, 

which is not a travel vaccine and would not be recommended for children who are traveling 

because it does not include A. 

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 0 Opposed: N/A
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Santoli replied that the eligible groups section could be amended to make that more clear. 

Vote: VFC Resolution for MenB Vaccines for Persons Aged 

≥10 Years at Increased Risk for Meningococcal Disease 

Dr. Harrison made a motion to approve the VFC MenB vaccines recommendation for persons 

aged ≥10 years at increased risk for meningococcal disease. Ms. Pellegrini seconded the 

motion. The motion carried with 15 affirmative votes, 0 negative votes, and 0 abstentions. The 

disposition of the vote was as follows: 

15 Favored: Bennett, Belongia, Bocchini, Campos-Outcalt, Harriman, Harrison, Karron, 

Kempe, Pellegrini, Romero, Reingold, Riley, Rubin, Temte, and Vazquez
 

0 Abstained: N/A
 

Additional Meningococcal Vaccine Public Comments 

Frankie Milley

Founder / National Director 

Meningitis Angels 

At the time my son, Ryan, got meningitis, there was a vaccine but there was no marketing, there 

was no recommendation, and there was no accessibility, so he died. With permissive 

recommendations, he still would have died because we still wouldn’t have known about it. You 

know, to me, this is like if you have a ship with 100 passengers on board, you have 100 life 

vests and that ship is sinking, you’d hand out 50 of those life vests and the other people watch 

theirs hanging in the closet as they drown. You’ve done a great job in protecting these kids so 

far from this disease. We’ve got half of the puzzle there. We need to finish the puzzle. I am 

really encouraging you, as you move forward, to work fast on this because I really believe a 

permissive recommendation in an outbreak—somebody’s going to die before that happens or 

be left debilitated. That’s wrong. We shouldn’t have to have a sacrificial lamb. I would 

encourage you to move away from those living in dorms. We’ve been fighting this 10 years and 

we still argue with physicians every day that they don’t have to live in a dorm to get this. Five of 

our kids were told, “You don’t live in the dorm. You don’t get the vaccine.” All five of them died. 

So, I just want to encourage you to really think about moving fast on this issue so other kids 

don’t die. Thanks again. 

Scott Parkhurst 

Meningitis Angels 

My son Jake is the youngest of two of my boys. He was an A student Junior in high school. He 

loved golf. He skied, snowboarded, and rode motorcycles. He was into baseball. I got a call 

Saturday night about a year ago to the day that he wasn’t feeling well. He was with his mom 

and I said, “Drink your fluids and we’ll see how you feel in the morning.” The next morning, I 

texted him to follow up on how he was feeling, and he said his mom was taking him to urgent 

care. At 10:30 Monday morning, I texted his mom and she said was being put in an ambulance 

to take him to the hospital. I drove to the hospital. I was in the ER and the doctor pulled me 

and his mom aside and said, “He may not make it.” I said, “Fight for your life” and he nodded 

his head. They took him to ICU and he was in a medically-induced coma. They had to help him 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

fight with antibiotics. Later that evening, they noticed that one of his pupil’s was dilated and they 

thought there might be some brain issues, and so they started to wean him off of the 

medication. He wasn’t showing any responsiveness, so they did an EEG and determined that 

he was brain-dead. Jake was dead in 36 hours—cause of death, Meningitis B. I took my oldest 

boy to Canada to get him vaccinated for Meningitis B. I believe a permissive recommendation 

would be the death of Jake all over again. Thank you. 

Andy Marso

Meningitis Angels 

I prepared some remarks, but obviously, I just kept paring them down and paring them down. In 

the interest of time, I wrote a 270-page book about my experience, so if you want it, Dr. 

Pickering has a copy. Really, the time element here doesn’t necessarily matter because no 

matter how much time I had, I wouldn’t have been able to convey to all of you the horror of 

going from a completely healthy college student to within 24 hours being life-flighted on a 

helicopter to a Level 1 trauma center with my lungs failing and struggling to breathe. I wouldn’t 

be able to convey to you what my parents felt when they arrived that night, and I was already 

unconscious, and the doctors told them I might not survive. I wouldn’t be able to convey to you 

the deep distress of waking up from that coma three weeks later and realizing I couldn’t move 

my hands and feet, and having doctors remove the bandages to show me that my arms and 

legs were rotting while still attached to my body. I would not be able to convey to you the pain 

of the next three months, both physical and emotional, that I spent in a burn unit at KU Medical 

center having my arms and legs debrided daily. I would not be able to convey to you the postsurgical pain of amputations that were still necessary to my feet and hands. I would not be able 

to convey to you the frustration of the year of physical and occupational therapy that I needed to 

be able to wipe myself and feed myself as a 23-year old man. 

No matter how much time you could give me, it would not repay my father’s insurance company 

for the $2 million in medical bills that we billed them that first year. It would not compensate me 

for all of the thousands in out-of-pocket costs I have paid every year since for my medical 

needs, including my prosthetics to walk and to stand. Those costs will be with me for the rest of 

my life. When you consider these recommendations, please consider not just the costs, but the 

cost burden. Mass vaccination spreads that cost burden equitably among a large population. 

Neglecting to vaccinate large populations concentrates the cost burden for this disease on 

families like mine, and it is enormous. The recommendation that you all made today is a start, 

but it’s barely a start. What it basically says is that if you go to a school like the University of 

Missouri where they just had a confirmed MenB case, you’ve got to wait for two more people to 

get sick because that’s a big school. So, they’re not going to bring in the vaccine until at least 

two more people critically ill. That’s not acceptable. That’s not preventative medicine. That’s 

crisis management, and it’s not even very effective crisis management. I would much rather 

see us prevent this before it happens. So, what I encourage you all do is be bold and consider 

your legacy. We have a chance to wipe out a disease that causes incalculable human suffering. 

One of the most important pieces of that puzzle is your recommendation. Thank you. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Lynn Bozof

National Meningitis Association (NMA)
 

I have no disclosures to make. As many of you know, NMA is comprised of survivors and 

families who have all suffered tremendously from meningococcal disease. In January, NMA 

hosted a round table of survivors, their family members, infectious disease specialists, college 

health officials, and others who could all offer a unique perspective and knowledge about 

meningococcal disease. We would like to share the outcome from that meeting, which is in your 

packet and also is available on the back table. It gives voice to the concerns and worries of the 

participants. The report points out the long-term impact on survivors, the life-altering changes 

for all of their families, and the effects on an entire community long after the immediate impact. 

So, as others have said, as you consider serogroup B recommendations in light of all of the 

cases and outbreaks that have occurred recently, please consider these life-altering and lifechanging perspectives. I’ve heard from so many families who have lost children to the B 

serogroup who thought their children had been protected because they had been vaccinated 

according to CDC recommendations. We now have the tools to protect against the most 

common strains of this disease. We need to do the right thing and routinely recommend 

vaccination for adolescents and teens. It’s the only way that parents who rely on physician 

recommendations can have the opportunity to fully protect their children. Thank you. We have 

a short PSA to show. 

Patty Wukovits

National Meningitis Association (NMA)
 

In 2012, my beautiful daughter, 17 year old Kimberly, a healthy high school senior in New York, 

died of serogroup B meningococcal disease just one week before graduating. We buried her in 

her prom dress just two days before she would have been able to wear it at her prom. I’m a 

nurse, and when Kim got sick, I was sure it wasn’t meningitis because she’d been vaccinated. I 

assumed that the recommended vaccine covered it all and I thought she was safe. After losing 

Kim, I dedicated myself to learning more. There were no approved serogroup B options then, 

but there are now. Please try to think about the message that parents will hear, “The CDC 

recommended that your child be vaccinated against meningococcal disease, but this vaccine 

won’t protect against all strains of the disease. There is an additional vaccine that protects 

against the strain most common in adolescents. It is not recommended, but your child can get it 

if you want it and if you’re able to obtain it.” As a health care professional, this is an extremely 

complicated message to deliver and, more importantly, it’s a hard message for a parent to hear 

and understand. We cannot expect parents to know that their children are not protected against 

serogroup B, and we cannot expect health care providers to act without strong guidance from 

this committee. That’s why I’m asking you to consider broad recommendations for this vaccine. 

A recommendation would make it easy for parents to do the right thing to vaccinate their 

children. The bottom line is Kimberly would be alive today if she had had the opportunity to 

have been protected by the B vaccine. Instead, as her mother, I am standing here literally in 

Kim’s shoes, the very shoes she should be wearing right now in her third year of nursing school 

fulfilling her dreams to become a pediatric nurse. Please help ensure that all children get the 

protection they need so that what happened to my family and to Kimberly does not happen 

again. Thank you. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Carl Buher
 

National Meningitis Association (NMA)
 

Thank you guys. I’m so grateful to have the chance to speak here today representing the 

National Meningitis Association. I survived bacterial meningitis when I was 14, and just last 

year learned that it was serogroup B. I spent five months in the hospital, lost three of my fingers 

and both of my legs below the knee on Halloween. I had 11 surgeries. It took me almost four 

years to learn to walk again on my prosthetics. To date, my medical bills have far exceeded $2 

million, but I still consider myself lucky. Eleven years later, I have a college degree, a great job, 

and a beautiful wife. Most survivors I know feel the same way. We have pretty good attitudes 

and have been able to find the positives in this disease. For example, my wife and I like to talk 

about my perks list, which includes things like my feet no longer fall asleep and the ability to 

know exactly what shoe size I need. However, there are also some cons. I can no longer enjoy 

fuzzy slippers and Ziploc® bags have become my worst enemy. But no matter how lucky we 

are, most of us will deal with the effects of this disease for the rest of our lives. My fellow 

survivor, Samantha, has had more than 37 surgeries in 30 year and still has pain on a daily 

basis. Kyla lost both legs and most of her fingers and has gone through a dozen surgeries in 

recent years to lengthen her thumb, because she says “opposition is everything.” Blake learned 

so much as an outpatient before a transplant that he became a dialysis nurse. Some of us, Like 

Francesca, have invisible scars like the loss of cognitive function, or hearing, or vision. Many of 

us endured and some continue to endure anxiety, fear, and depression because of this terrible 

disease. When we get together, we talk about the challenges we deal with that most people 

don’t even think about, like how to take a shower when you’re traveling with no legs or how hard 

it is to count to 10 on your fingers when you’re missing a few. For most of us, it will affect our 

finances for the rest of our lives. Our cost of living will always be higher, and we may need 

additional support and more obvious things, such as needing more time off work to deal with 

additional surgery or complications. Even with great insurance plans, we pay enormous copays and out-of-pocket expenses for other things no insurance will cover, such as retrofitting 

cars to fit our needs or renovating homes. We are all very different, but one thing we agree 

on—we don’t want anyone to have to go through what we went through and still deal with it on a 

daily basis. When you look at the cost of prevention, I hope you’ll calculate how high the cost of 

survival is as well. Thank you for your time. 

Sally Greenberg 

Executive Director 

National Consumers League 

I’m here to support the routine schedule of Meningitis B. My organization has been around 

since 1899. We are the oldest consumer organization, and we also survey consumers on their 

attitudes about vaccines. What we found in our latest survey was that 87% of parents support 

getting their children vaccinated. The disease they fear most that vaccinating can prevent is 

meningitis. So, I’m here also to support the many parents and families who came out at their 

own expense. I come to this as a consumer advocate and wearing several other hats. One is 

that I had an uncle who had polio. He got it the year before the polio vaccine came out, and I 

watched my family suffer while he clung to life in an iron lung for two years and then went on to 

be a quadriplegic. One year later, this tragic condition could have been prevented. I’m also the 

parent of a college-aged kid who is a baseball player and lives in the dorms. As I meet with a 

lot of the meningitis victims, we take a very strong stand in favor and in support of safe and 

effective vaccines. I’m finding it very difficult to access that vaccine for him. It would be 

wonderful if this vaccine became part of the routine schedule. They have to order it. They’re 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

not sure which one they want to order. There’s a wealth of confusion. I’ve had maybe 10 

phone calls and we still haven’t figured out how to get this vaccine. So, it really isn’t fair for my 

son to be the only guy to get it on his campus, which he probably will be. But, you know, I really 

feel so strongly that when you have something that’s safe and effective, and thanks to all of you 

for the critically important work that you do, but there’s just no reason why this shouldn’t be part 

of the routine schedule. So, I’m really here with lots of hats on, but I think most importantly to 

support all of these families—the parents who came forward with these devastating conditions 

as a result of contracting Meningitis B and something that’s totally preventable. Thank you for 

giving me the chance to speak. I appreciate it. 

Additional Comments 

Dr. Temte indicated that four letters pertaining to meningococcal infection and disease were 

submitted, and would be subsumed into the official minutes of the meeting. Those letters follow: 

Leslie Maier 

National Meningitis Association 

Via Letter to Dr. Temte Date 2-24-15 

Dear Mr. Temte: 

My name is Leslie Maier and I am on the Board of Directors for the National Meningitis Association. I live in Tucson, 

Arizona. My son Chris was 17 and a senior in high school when he contracted meningococcal disease and died in 

less than 24 hours. The new meningitis vaccine was not available at that time for his age group. I believe he would 

be alive today had it been recommended. 

I’m contacting you to request you write a letter to the Centers for Disease Control and Prevention’s Advisory 

Committee on Immunization Practices asking them to routinely recommend vaccines to protect adolescents against 

serogroup B meningococcal disease. 

The FDA recently approved the first vaccines to protect against serogroup B in the United States. Since 2005, the 

CDC has recommended a vaccine to protect against strains A, C, W and Y, at age 11-12 with a booster dose at age 

16. Many parents with children who suffered from serogroup B did not know that the vaccine their child received did 

not protect them against it. 

Serogroup B meningococcal disease was also the cause of recent college outbreaks at Princeton University and 

UCSB. In the last 5 months, at least 2 other college students, in cases unrelated to these outbreaks, died from 

serogroup B. In the past month there were at least 5 more cases reported on college campuses across the United 

States. 

I am one of the people affected by this horrible disease. My son’s death devastated our family and community. 

Chris’ high school classmates had difficulty finishing their final year of high school. His sister became an only child 

and is saddened that her new son will never have nieces or nephews to grow up with. His father and I have 

experienced the greatest loss possible, that of our child. Our goal is that no one else has to experience this terrible 

disease. We share our story to educate others about meningococcal disease, stressing the importance of 

vaccination. 

A routine recommendation of serogroup B vaccines for adolescents would be a significant step forward in protecting 

them from this devastating disease. As someone whose life was profoundly affected by this disease, I encourage 

you to write a letter to the ACIP committee prior to their Feb. 25 meeting to help protect our children. 

Sincerely, 

Leslie Maier 

National Meningitis Association 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

February 20, 2015 

Dr. Tom Frieden 

Director 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329-4027 

Dear Director Fieden: 

Our organizations, which together represent low-income and minority communities 

frequently disadvantaged in access to quality medical care, are writing as members of the Health 

Disparities Working Group. We urge you to give the two vaccines for bacterial meningitis 

(MenB) currently under consideration by the Advisory Committee on Immunization Practices 

(ACIP) a permissive recommendation at the Feb. 25, 2015 meeting. 

The Affordable Care Act contained important provisions intended to address the vaccine 

gap in our country. Before passage of the law, this disparity meant vaccines were readily 

accessible to affluent communities, while low-income and minority communities lacked 

equivalent access. The National Institutes of Health (NIH) has identified access to vaccines as a 

major factor in curbing health disparities. Studies have found that minorities are less likely to 

receive immunizations because of limited access to preventative healthcare and lack of 

education on the importance of regular vaccinations. A recent Centers for Disease Control and 

Prevention (CDC) report found large racial, ethnic and income disparities in preventable 

hospitalizations, where blacks experience a rate more than double that of whites. Preventable 

incidents account for more than 1 million hospitalizations each year, at a cost of more than $6.7 

billion annually. 

The Affordable Care Act attempts to equalize vaccine access by requiring that the 

Vaccines for Children Program – which provides approximately 82 million vaccines to 40 

million low-income children each year – cover vaccines to which ACIP has given a permissive 

recommendation. Private insurance must follow suit. But if ACIP only approves the vaccines for 

certain groups deemed high-risk or following an outbreak, vulnerable populations simply won’t 

have access to the vaccines. 

This deadly bacterial strain accounts for about 40 percent of meningitis cases in the 

United States. While rare, there have been some 50 adolescents that have been struck with it 

each year in recent years. Outbreaks on college campuses have been widely covered in the 

media given the deaths and amputations that have resulted. But in addition to college students, 

minority communities are also at great risk. Many low-income black families face key risk 

factors for bacterial meningitis, including over-crowding, underlying illnesses and tobacco use. 

Victims of this disease are all too aware of its severity and devastating implications, and 

no more families should be put at risk by limiting the recommendation. The United States owes 

its most vulnerable citizens a long-term, proactive prevention strategy for MenB, rather than a 

reactive one that waits for tragedy before taking action. 

Our organizations have sought to raise awareness about the growing disparity in health 

for low-income and minority families in the United States, which NIH recently labeled as one of 

the nation's greatest challenges. We strongly support efforts by ACIP to address the current 

vaccine gap and the devastating impact it has had on at-risk communities around the country, 

and we urge its members to grant a permissive designation to the MenB vaccines. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Sincerely, 

MINORITY VACCINE DISPARITIES ALLIANCE 

Dr. Christopher J. Metzler, CEO, Fitness, Wellness & Health 

Georgia Buggs, M.P.H, RN, Former member, U.S., Department of HHS, The National Vaccine 

Advisory Committee (NVAC) 

Cc: Dr. Larry K. Pickering 

Executive Secretary 

Advisory Committee on Immunization Practices 

Influenza 

Introduction 

Ruth Karron, MD 

Chair, Influenza Work Group 

Dr. Karron thanked the WG for a tremendous effort, particularly over the last couple of months 

as they considered a lot of very late-breaking data. Since October 2014, the WG has engaged 

in continued discussion of the effectiveness of live attenuated influenza vaccine (LAIV) and 

inactivated influenza vaccine (IIV) for both the 2013-2014 and the 2014-2015 influenza seasons. 

The WG has also reviewed data pertaining to the recently approved quadrivalent intradermal 

influenza vaccine. In the interest of time, some of the presentations were truncated. Included 

during this influenza session were updates on the interim vaccine effectiveness estimates for 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

the 2014-2015 season, an update on LAIV, and proposed recommendations for the 2015-2016 

influenza season. Additional information that was not presented was included in ACIP 

member’s packets, including an update on influenza surveillance and the new Fluzone® 

intradermal quadrivalent influenza vaccine. 

Preliminary 2014-2015 Vaccine Effectiveness Estimates 

Brendan Flannery, PhD

Influenza Division 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention 

Dr. Flannery presented brief updates on influenza vaccine effectiveness (VE) during the current 

season, and LAIV and IIV among children and adolescents from the US Flu VE network. The 

updated interim VE estimates were based on 4,913 patients with acute respiratory illness with 

cough of 7 or fewer days duration enrolled from November 10, 2014 through January 30, 2015. 

The study used a test-negative case-control design. All patients were tested for influenza and 

vaccination among influenza positive cases which was contrasted with that of influenza-negative 

patients. Of the enrollees, 67% were influenza negative and 33% were influenza positive. Of 

the influenza positive cases, 94% were type A and all subtyped A viruses were H3N2. More 

than half (n=764) of the H3N2 viruses were genetically characterized at CDC using a novel 

pyrosequencing assay that determines genetic group, from which antigenic properties can be 

inferred. Of the H3N2 viruses from US Flu VE network participants, 85% belonged to genetic 

groups that are generally low reactors with A/Texas/50/2012, while only 15% of H3N2 viruses 

were genetically more vaccine-like. Among influenza B cases from the Flu VE network, most 

were B Yamagata lineage, the B lineage included in both the trivalent and quadrivalent 2014­

2015 vaccines. 

In terms of the early interim VE results from the January 16, 2015 MMWR report, adjusted VE 

against A(H3N2) illness was 18% with a 95% confidence interval from 6% to 29%. None of the 

age-specific estimates for A(H3N2) were statistically significant and all confidence intervals 

overlapped. There was evidence of higher VE against influenza B viruses. Adjusted VE against 

influenza B for patients of all ages was 45%, with a 95% confidence interval from 14% to 65%. 

For the 2014-2015 season, numbers of genetically characterized H3N2 viruses from patients 

enrolled in the US Flu VE network were sufficient to provide interim estimates of VE against 

predominant genetic groups of H3N2 viruses. Regarding adjusted VE against H3N2 illness for 

patients aged 6 months and older, 115 H3N2 viruses were genetically characterized as vaccinelike groups 3C.3 or 3C.3b, and 39% of these patients were vaccinated this season compared to 

57% of influenza-negative patients. Adjusted VE against vaccine-like H3N2 viruses was 49%, 

with a confidence interval from 18% to 69%, suggesting that the vaccines perform better against 

vaccine-like viruses. Of the cases, 624 were due to group 3C.2a and 25 were due to group 

3C.3a. This indicates no or low VE against viruses in these antigenically drifted or low-reactor 

groups, albeit with wide confidence intervals. Of note, the reference virus from the 3C.3a group, 

the Switzerland virus, was selected for the 2015-2016 influenza vaccines. There is crossreactivity from the more common viruses from the 3C.2a group. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Regarding interim 2014-2015 VE, subjects aged 2 through 17 years of age were included in the 

VE analysis for LAIV and IIV among children and adolescents. Children who had received at 

least 1 dose of current season vaccine at least 14 days prior to illness onset were considered 

vaccinated for this analysis. Vaccine type was determined from the medical record if available, 

but parent report of vaccine type was used if no medical record documentation was available. 

Twelve children with unknown or unreported vaccine type were excluded. Vaccine 

effectiveness was calculated separately for LAIV and IIV, where patients unvaccinated this 

season were the referent group. 

With respect to the interim adjusted VE estimates against H3N2-positive cases for one or more 

dose of 2014-2015 influenza vaccine by vaccine type, adjusted VE for one or more dose of any 

vaccine among 2 through 17 year olds was 7% with confidence intervals overlapping zero, or no 

effectiveness. Estimates for younger and older children were similar. Analyses for LAIV 

excluded children who received IIV. Similar proportions of influenza-positive and influenzanegative children received LAIV this season. Adjusted VE ranged from -20% to -24% with 

confidence intervals overlapping zero, suggesting no effectiveness for LAIV against H3N2 

viruses so far this season. Analyses for inactivated vaccine excluded children who received 

LAIV. Adjusted VE estimates ranged from 15% to 19%, again with confidence limits including 

no effect and overlapping with confidence intervals for VE estimates for LAIV. 

MedImmune is also conducting an observational study of vaccine effectiveness at four sites in 

the US. Interim 2014-2015 results from this study were prepared by MedImmune and shared 

with CDC for comparison with results from the US Flu VE Network. The study enrolls patients 

aged 2 through 17 years presenting with febrile respiratory tract illness of less than 5 days 

duration. Vaccination status is determined by medical record or registries and subjects 

vaccinated fewer than 14 days before onset are excluded. Influenza is confirmed by 

polymerase chain reaction (PCR) and influenza PCR-negative subjects are the comparison 

group. This analysis included 988 enrollees. 

Regarding the number of influenza-positive cases and influenza-negative controls in each group 

of children and adolescents according to receipt of 2014-2015 influenza vaccine, adjusted VE 

for any vaccine against any influenza was 27% with 95% confidence intervals from -1% to 47%. 

Adjusted VE for LAIV was 19% and for IIV was 31%, with confidence intervals that included 

zero and that overlapped. Adjusted VE against H3N2 was 16% for LAIV and 33% for IIV, which 

reached statistical significance. There were too few influenza B cases to produce reliable 

estimates of VE by vaccine type for influenza B in children and adolescents. 

In conclusion, low interim VE estimates are consistent with predominance of antigenically drifted 

H3N2 viruses. H3N2 accounted for 95% of influenza-positive cases at US Flu VE network sites, 

and more than 80% of genetically characterized H3N2 cases were substantially drifted from the 

H3N2 vaccine virus. In analyses by a viral genetic group, low or no VE was observed against 

drifted H3N2 viruses. There was limited circulation of vaccine-like H3N2 and influenza B 

viruses against which VE was higher. Interim VE estimates from the two studies provide no 

evidence of better protection for LAIV in the 2014-2015 season with the predominance of drifted 

H3N2 viruses. For final season VE estimates from the US Flu VE Network, the plan is to 

complete the genetic characterization of influenza viruses and update VE estimates for LAIV 

and IIV with verification of vaccine type and prior vaccination, comorbidities, and further analysis 

of differences in circulating viruses by site. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Flannery acknowledged the many contributors to the US Flu VE Network at the five 

participating sites, his CDC colleagues, and the investigators from MedImmune who shared 

their preliminary data for this presentation. 

Update: Live Attenuated Influenza Vaccine (LAIV) 

Kathleen Coelingh, PhD 

MedImmune 

Dr. Coelingh expressed appreciation for the opportunity to present an update on the 

effectiveness of LAIV. The results presented were from an investigation into the observed low 

effectiveness of LAIV against the H1N1 strain in 2013-2014 and the actions MedImmune is 

going to take to ensure the high effectiveness of LAIV in future seasons. MedImmune has 

discussed its findings in detail with the Influenza WG and, at their request, shared an 

abbreviated summary during this session. 

In summary, moderate to high effectiveness of LAIV was observed for A/H3N2 and B stains in 

children in 2010-2011, 2011-2012, 2012-2013, and 2013-2014 and for all matched strains in 

prior studies. However, low effectiveness was observed for A/California H1N1pdm09 strain in US in 

2010-2011 (trivalent formulation) and 2013-2014 (quadrivalent formulation). MedImmune has concluded 

that this issue is specific for A/California H1N1pdm09 LAIV and may be US-specific as LAIV appeared 

effective in Canada in 2013-2014. 

The low effectiveness of A/California LAIV is not explained by manufacturing, poor stability 

under recommended storage (36-46°F), antigenic mismatch, prior vaccination, pre-existing 

immunity, or vaccine strain interference. MedImmune’s best explanation is that the A/California 

H1N1pdm09 strain has a unique HA stalk sequence that compromises the stability of its hemagglutinin, 

making the strain less fit and more vulnerable to heat degradation. HA heat stability appears linked to 

the effectiveness of that California strain because detailed analysis of the available 

effectiveness data shows that vaccine shipping when outdoor temperatures are >80°F 

correlates with reduced effectiveness for A/California LAIV, but not other LAIV strains. To 

remedy this in the future, MedImmune will replace the A/California LAIV strain with an antigenically 

matched strain with a more stable HA. 

With regard to recent VE data from recent studies in the US and Canada, in terms of VE against 

H3N2 and B strains in children 2 through 8 years of age in the CDC and MedImmune studies 

conducted during four recent seasons, LAIV effectiveness was consistently moderate to high 

against H3N2 and B strains in every season. In terms of effectiveness against the H1N1pdm09 

strains, the strain contained in the LAIV was always the A/California strain in all of the studies. 

LAIV was effective against H1N1 in the 2009-2010 season, but not in the 2010-2011 or 2013­

2014 seasons. To summarize, in the US, LAIV was consistently effective against H3N2 and B 

strains, but had variable effectiveness against the H1N1pdm09 strains. 

A different picture was seen in the Canadian studies conducted in 2013-2014 by Dr. Danuta 

Skowronski, who kindly shared them with MedImmune. LAIV was highly effective in Canada 

against any influenza strain in individuals under 20 years of age and in children 2 to 8 years of 

age, which was statistically significant. As noted, 59% of the strains in the study were H1N1. 

The results were similar when looking at H1N1pdm09 strains only. However, due to fewer 

cases, these estimates had wide confidence intervals and were not statistically significant. 

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These results are supported by the results of a second Canadian study conducted by Jeffrey 

Kwong, which he presented during the Canadian Immunization Conference in December 2014. 

This was a cluster-randomized trial with LAIV and IIV in elementary school children in Ontario in 

2013-2014. The incidence of influenza in the children was significantly lower among LAIV 

recipients compared to IIV recipients, indicating that LAIV did protect against the H1N1pdm09 

strain in Canada in the 2013-2014 season. These results support the conclusion that the low 

effectiveness of LAIV against the H1N1 strain may have been US-specific. 

Dr. Coelingh next focused on the hypothesis that is consistent with all of the data she showed 

and is the most biologically plausible explanation for the low effectiveness of the A/California 

LAIV strain in two recent influenza seasons in the US. It is believed that the unique A/California 

HA stalk sequence explains the low LAIV effectiveness against H1N1 in some of the US 

studies. The A/California wild-type and LAIV have a glutamic acid at Position 47, which is 

abbreviated E47, in the HA stalk that reduces the HA trimer stability and viral fitness. E47 is not 

present in seasonal viruses and is not prevalent in the current H1N1pdm09 strains. When the 

A/California strain is replaced in the upcoming season with a more recent H1N1 strain, that 

strain will not possess the E47 and will have enhanced HA stability and viral fitness. 

MedImmune has shown that the E47 sequence significantly reduces infectivity in ferrets and 

increases vulnerability to heat degradation with temperatures between 120 0 and 1600F. T 

way to think about these experiments is that it takes more heat to pull apart a stable HA than it 

does to pull apart an unstable HA. The A/California LAIV strain with E47 in its stalk is readily 

differentiated from other seasonal Type A and B LAIV strains, including LAIV strains with known 

efficacy. Given the A/California strain’s increased vulnerability to heat degradation, 

MedImmune hypothesized that even relatively minor and routine exposures to temperatures 

above the recommended storage temperature of 36° to 46°F could lead to potency loss, which 

in turn could lower the real-world effectiveness. 

In the normal US distribution process, exposures to temperatures over 70° can occur at multiple 

points after leaving the MedImmune chain of control. Standard processes permit vaccine 

exposure to room temperature up to 79° for up to two hours after unloading from refrigerated 

trucks at distributors and also while packing out shipments to customers. In fact, MedImmune 

has documented that one of the lots most frequently used in both the MedImmune and CDC 

studies in 2013-2014 was outside the refrigerated warehouse for 1 hour and 15 minutes at the 

distributor. MedImmune has recently shown that a 1-log decline in A/California potency occurs 

after 24 hours at 91°, and is now studying the impact of shorter term exposures on strain 

potency and infectivity. 

In the following graphic, the proportion of MedImmune recipients in the MedImmune and CDC 

studies who had H1N1 illness is on the vertical axis. On the horizontal axis is the temperature 

at the distributor sites on the date and time of truck unloading. Each circle on this graph 

represents a separate lot, and the size of the circle corresponds to the number of subjects 

receiving the lots in the studies. The actual number of recipients in each lot is given inside the 

circles: 

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As illustrated in this graphic, there is a strong and significant correlation between lot 

effectiveness and the outdoor temperature when the truck was unloaded at the distributor, with 

a cut point to around 80°. This suggests that the temperature exposure at the distributors 

during unloading may have adversely affected the performance of the A/California LAIV strain, 

which is consistent with this strain’s increased vulnerability to heat degradation. 

A similar association was shown between reduced A/California effectiveness and shipping 

during hotter weather, before mid-September. LAIV effectiveness against H1N1 was low in 

2010-2011 and 2013-2014 in the US when most of the doses were shipped during warmer 

weeks before mid-September. In contrast, LAIV effectiveness against H1N1 was high in 2009­

2010 in the US and 2013-2014 in Canada when doses were shipped in the cooler weeks after 

mid-September. This analysis is consistent with the hypothesis that the lower fitness of the 

California strain, its vulnerability to high temperature, and its potential exposure to temperatures 

above 36° to 46° during distribution reduced the effectiveness of the A/California LAIV strain in 

two influenza seasons. 

All of this brought MedImmune to its leading hypothesis that the reduced fitness and increased 

vulnerability of the A/California LAIV to heat degradation could explain the variable effectiveness 

of LAIV against H1N1 strains. Critical to this hypothesis is that it is known, from previous 

randomized control trials (RCTs), that LAIV efficacy can be significantly reduced at 1-log lower 

potency. The key point is that the primary deficiency is the unique characteristics of the 

A/California HA. The recent H3N2 and B strains, which do not have the unique vulnerability of 

the California strain, have been effective in all recent seasons. This is consistent with 

MedImmune’s multiple previous RCTs. 

Regarding MedImmune’s plans for the 2015-2016 and future influenza seasons, the primary 

remedy is to replace the A/California strain in the 2015-2016 vaccine with an antigenically 

similar strain with a more stable HA. This strain will not contain the E47 residue, and will have a 

heat tolerance similar to strains with demonstrated effectiveness. 

As mentioned earlier, none of the other LAIV strains have been ineffective, even though all of 

them were subject to the same distribution process and potential temperature exposures. This 

highlights that the normal LAIV strains are really quite resilient, and that A/California is the 

outlier in this respect. Nevertheless, MedImmune is working with its US distributors to eliminate 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

any significant exposures above the recommended storage temperature of 36 0 to 460F durin 

shipping and handling. 

Going forward, additional effectiveness data are expected for quadrivalent LAIV from several 

studies as shown in the following table: 

In closing, MedImmune is confident that the replacement of the A/California H1N1pdm09 strain 

with a more robust strain with a more stable HA will result in future effectiveness that is 

consistent with what has been observed previously in LAIV in RCTs, and with what has been 

observed for other strains in the recent observational study. 

Discussion Points 

Dr. Karron requested clarity regarding whether it was correct that during the 2013–2014 season, 

the US was using quadrivalent vaccine and Canada, where effectiveness of H1N1 was 

demonstrated, was using trivalent vaccine. However, moving forward, it will be possible to 

compare quadrivalent to quadrivalent because all countries are now using quadrivalent. 

Dr. Coelingh confirmed that this is correct. To make it easy for everybody, starting with the 

upcoming 2015-2016 season, everything will be quadrivalent globally. There will be data from 

the 2014-2015 season from other countries using quadrivalent. 

Dr. Romero asked what measures are in place to check the stability of future strains, given that 

this is probably not just an anomaly and happens more frequently than realized. 

Dr. Coelingh replied that MedImmune routinely makes its own strains, so they are responsible 

for ensuring that they choose the absolute best, most optimal strain. While screening for HA 

stability was not part of MedImmune’s routine screening as this phenomenon had not been 

observed in the past, incoming strains being considered for inclusion in the vaccine are now 

being screened. She referred members to the backup slides in their handouts that showed that 

in the laboratory, it is possible to discriminate reliably between strains that have this unique 

characteristic and do not have heat stability. Though screening is done by sequence, it is more 

important to screen by actual function—to actually pressure-test it in the laboratory to determine 

which strains might be more optimal than others in terms of having better HA stability. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Reingold asked what is known about vaccine handling where it is being administered in 

terms of how long it might be left out. This is particularly important, given that vaccine is being 

administered increasingly in pharmacies and a variety of other places. 

Dr. Coelingh responded that LAIV is quite stable even at 25° or what would be called “room 

temperature.” In the clinic setting, vaccine is very resilient to being left out for a day. While she 

did not have specific knowledge about how vaccine is actually handled by providers, she 

surmised that there is probably an entire range. The goal in MedImmune’s stability program is 

always to monitor vaccine at the recommended storage temperature of 2° to 8°, or refrigeration 

temperature, or 35° to 46° F. While MedImmune’s stability program monitors the recommended 

storage temperature, they also go outside because it is known that some people like to prepare 

for a large clinic and they do not thaw one-by-one. MedImmune is very careful to ensure 

stability under those types of conditions as well. 

Dr. Kimberlin (AAP) requested a reminder regarding VE during the 2013-2014 season for 9 

through 17 year olds and whether it was statistically significant. 

Dr. Coelingh replied that VE trended higher in 9 through 17 year olds than in the 2 through 8 

year olds, which was a surprising finding. The finding was not statistically significant. 

Dr. Loehr (AAFP) recalled that Dr. Coelingh mentioned that MedImmune’s hypothesis is that it is 

a stalk on the H1N1. Dr. Flannery's presentation on VE for this year showed that the LAIV was 

not working particularly well this year and that it is an H3N2 season. He requested that Dr. 

Coelingh comment on that. 

Dr. Coelingh indicated that what she presented during this session showed the occurrence in 

2013–2014 that was related to the stalk sequence. The situation in the current season is 

entirely different, wherein the mismatch is significant. For H3N2 strains, Medimmune has 

shown good protection in the past against some of the mismatched strains. For example, in 

1997, there was Sydney/Wuhan and in the comparative Belshe study in 2004-2005, there was 

also an H3 mismatch and the efficacy was really high in the eighties. Her own thought is that 

the kind of protection against a drifted strain that will be seen from any vaccine is dependent 

upon the degree of the match and mismatch. There are limits for every vaccine in terms of what 

degree of mismatch it is still going to work against. After all, the vaccine is changed every year 

to try to match it, and there is a reason why that is done. 

Proposed Recommendations 2015-2016 Influenza Season 

Lisa A. Grohskopf, MD, MPH 

Influenza Division 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Dr. Grohskopf acknowledged the Influenza WG members, as well as the many other people 

involved in the work that goes into compiling all of this information. For this meeting, there were 

two proposed recommendations for the next influenza season: 1) a reiteration of the core 

recommendations, and 2) proposed revisions for the upcoming season. The following language 

was proposed for a vote during this session: 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Reiteration of Core Recommendations 

Annual influenza vaccination is recommended for all persons 6 months of age and older: 

 A licensed, age-appropriate influenza vaccine should be used 

 Recommendations for different vaccine types and specific populations discussed 

in the ACIP statement 

Use of LAIV for Children 2 Through 8 Years of Age Current Language (2014-2015) 

 When immediately available, LAIV should be used for healthy children aged 2 through 8 

years who have no contraindications or precautions. 

Proposed revision (2015-2016) 

 For healthy children aged 2 through 8 years who have no contraindications or 

precautions, either LAIV or IIV is an appropriate option. No preference is expressed for 

LAIV or IIV for any person aged 2 through 49 years for whom either vaccine is 

appropriate. 

LAIV Recommendations (Proposed)—1 

 All persons aged ≥6 months should receive influenza vaccine annually. Influenza 

vaccination should not be delayed to procure a specific vaccine preparation if an 

appropriate one is already available. 

 (Proposed revision) For healthy children aged 2 through 8 years who have no 

contraindications or precautions, either LAIV or IIV is an appropriate option. No 

preference is expressed for LAIV or IIV for any person aged 2 through 49 years for 

whom either vaccine is appropriate. An age-appropriate formulation of vaccine should be 

used. 

LAIV Should Not Be Used for the Following Persons (Proposed)—2 

 Persons aged <2 years or >49 years 

 Children aged 2 through 17 years who are receiving aspirin or aspirin-containing 

products 

 Persons who have experienced severe allergic reactions to the vaccine or any of 

its components, or to a previous dose of any influenza vaccine 

 Pregnant women 

 Immunosuppressed persons 

 Persons with a history of egg allergy 

 Children aged 2 through 4 years who have asthma or who have had a wheezing 

episode noted in the medical record within the past 12 months, or for whom 

parents report that a health care provider stated that they had wheezing or 

asthma within the last 12 months 

 Persons who have taken influenza antiviral medications within the previous 48 

hours 

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

 

 

 0 Opposed: N/A 

1 Abstained: Belongia 

 

 

Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

LAIV Recommendations (Proposed)—3 

In addition to the groups for whom LAIV is not recommended above, the “Warnings and 

Precautions” section of the LAIV package insert indicates that persons of any age with 

asthma might be at increased risk for wheezing after administration of LAIV, and notes that 

the safety of LAIV in persons with other underlying medical conditions that might predispose

them to complications after wild-type influenza infection (e.g., chronic pulmonary, 

cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or 

metabolic disorders [including diabetes mellitus]) has not been established. These 

conditions, in addition to asthma in persons aged ≥5 years, should be considered 

precautions for the use of LAIV. 

LAIV Recommendations (Proposed)—4 

 Persons who care for severely immunosuppressed persons who require a protective 

environment should not receive LAIV, or should avoid contact with such persons for 7 days 

after receipt, given the theoretical risk for transmission of the live attenuated vaccine virus. 

Vote: Recommendations 2015-2016 Influenza Season 

Dr. Bocchini made a motion to approve the recommendations for the 2015-2016 influenza 

season. Dr. Bennett seconded the motion. The motion carried with 14 affirmative votes, 0 

negative votes, and 1 abstention. The disposition of the vote was as follows: 

14 Favored: Bennett, Bocchini, Campos-Outcalt, Harriman, Harrison, Karron, Kempe, 

Pellegrini, Romero, Reingold, Riley, Rubin, Temte, and Vazquez 

Dr. Temte pointed out that despite the fact that ACIP made a strong recommendation in June 

2014 using the GRADE process with moderate evidence, ACIP can change as evidence 

changes. He saw this as the real power of both transparency and having a formal process by 

which ACIP considers all of the evidence and makes changes as appropriate. 

Human Papillomavirus (HPV) Vaccines

Introduction 

Joseph A. Bocchini, Jr, MD

Chair, ACIP HPV Vaccine Working Group 

Dr. Bocchini added his thanks to Dr. Pickering for his many years of leadership and his 

accomplishments as the ACIP Secretary. Due to the time constraints, the presentations for the 

HPV session were shortened to provide the members with the essential information that would 

lead to a vote. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

As a reminder, the 9-valent HPV (9vHPV) vaccine was licensed by the FDA on December 10, 

2014 for females 9 through 26 years of age and males 9 through 15 years of age. Trials were 

conducted with a 3-dose schedule. This is an L1 VLP vaccine similar to quadrivalent HPV 

vaccine, which targets 5 additional high risk oncogenic types (31, 33, 45, 52, and 58). In the 

US, these types are estimated to cause 14% of HPV-related cancers in women and 

approximately 5% of HPV-related cancers in males. Males 16 through 26 years of age were not 

part of the initial Biologics License Application (BLA) submitted to the FDA in 2013. Vaccine 

safety and seroconversion data from the trial in 16 through 26 year old males were presented to 

ACIP in October 2014. A supplemental BLA (sBLA) has been submitted to the FDA for this age 

group. 

The current recommendation for HPV vaccination in the US is for routine vaccination at age 11 

or 12 years. The vaccine series can be started as early as age 9. Vaccination is recommended 

through age 26 for females and through age 21 for males who have not previously been 

vaccinated or who have not completed the series. Vaccination is recommended for 

immunocompromised persons, including persons who are HIV-infected, and for men who have 

sex with men (MSM) through age 26. The current recommendation is for a 3-dose schedule 

given at 0,1-2, and 6 months. The following table shows the three licensed HPV vaccines that 

are currently available in the US: 

In preparation for the vote during this session, a number of presentations have been provided to 

ACIP over the past year: 

 Epidemiology and burden of disease due to HPV types 

 February 2014 

 Clinical trial data 

 February 2014, June 2014, October 2014 

 GRADE for 9vHPV 

 October 2014 

 Health economic analysis 

 October 2014 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

 Discussion of policy options 

 October 2014 

Presentations during this session will focus on 9vHPV clinical trial data, vaccine impact and 

cost-effectiveness, considerations for recommendations, and a VFC resolution. 

Summary of 9vHPV Clinical Trial Data and GRADE 

Emiko Petrosky, MD, MPH

EIS Officer 

Epidemiology and Statistics Branch

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention 

During this session, Dr. Petrosky presented a brief summary of 9vHPV clinical trial data, a 

review of GRADE for 9vHPV, and considerations for a 9vHPV recommendation. Listed in the 

following table are the 9-valent vaccine studies, which have all been previously presented to the 

ACIP: 

As a reminder, protocol 001 is the pivotal efficacy study that compared the 9-valent vaccine to 

the quadrivalent vaccine in adult females. There were also immunobridging studies and 

concomitant use studies, and one study assessing the 9-valent vaccine in prior quadrivalent 

vaccine recipients. Dr. Petrosky presented only the results from Protocol 001, as this was the 

pivotal efficacy study, and summarized the results and safety findings from the other studies. 

In Protocol 001, for the 5 additional types, the 9-valent vaccine demonstrated greater than 96% 

efficacy in preventing high grade cervical, vulvar, and vaginal disease, and 6-month persistent 

infection. For outcomes due to the 4 original types, the incidence of disease in either vaccine 

group was very low, and the 9-valent vaccine demonstrated comparable protection in preventing 

high grade cervical disease and anogenital warts. Both of the 9-valent and quadrivalent 

vaccines induced greater than 99% seroconversion for the 4 original types, and the geometric 

mean titers in the 9-valent vaccine group were non-inferior to the quadrivalent vaccine group. 

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In summary, the 9-valent vaccine trial demonstrated close to 97% protection against outcomes 

due to the 5 additional types and similar protection against disease due to the 4 original types. 

There was very little incidence of disease in either the 9-valent or quadrivalent vaccine groups. 

The 9-valent vaccine demonstrated non-inferior immunogenicity compared to the quadrivalent 

vaccine for the 4 original types. Although the data were not shown during this session, the 

vaccine also demonstrated non-inferior immunogenicity for all 9 HPV vaccine types in 

adolescent females and males compared to adult females, and in adult males compared to adult 

females—supporting the bridging of efficacy findings in adult females to these other groups. 

The concomitant use studies demonstrated no impact on immunogenicity and safety when the 

9-valent vaccine was administered concomitantly with meningococcal vaccine (Menactra®), 

Tdap vaccine (Adacel®), and Tdap-IPV vaccine (Repevax®). 

Regarding safety, the 9-valent vaccine was generally well-tolerated in over 15,000 recipients 

and had an AE profile similar to the quadrivalent vaccine across age, gender, race, and 

ethnicity, with the exception of a higher frequency of injection-site swelling and erythema in 

females of all age groups. Males had a lower frequency of adverse events compared to 

females, which is similar to what was observed in the quadrivalent vaccine program. 

As a reminder, GRADE for the 9-valent vaccine was presented to the ACIP in October 2014. 

The 9-valent vaccine policy questions developed by the workgroup were: 

 Should the 9-valent vaccine be recommended routinely for 11 or 12 year olds? 

 Should the 9-valent vaccine be recommended for females aged 13 through 26 years and 

males aged 13 through 21 years who have not been previously vaccinated? (also referred to 

as catch-up vaccination) 

The WG gave the overall evidence type for routine vaccination in females a ranking of 2, 

indicating that the data reflected a moderate level of evidence. The WG also gave the overall 

evidence for catch-up vaccination in females a ranking of 2. The following are the summary 

tables for routine and catch-up 9-valent vaccination in females: 

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– 

– 

– 

Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

The WG gave the overall evidence type for routine and catch-up vaccination in males a ranking 

of 3, indicating a low level of evidence. The following are the summary tables for routine and 

catch-up 9-valent vaccination in males. 

With regard to the considerations for formulating 9-valent vaccine recommendation, the data for 

the 9-valent vaccine are from randomized trials and immunobridging studies, and the WG gave 

an overall evidence type of 2 for females and 3 for males. The WG felt that the benefits of 9­

valent vaccination outweigh the harms and placed a high value on the prevention of outcomes 

due to the 9 HPV vaccine types. The 9-valent vaccine is expected to be cost-saving compared 

to the quadrivalent vaccine. In conclusion, the WG proposed a Category A recommendation for 

the 9-valent vaccine. 

Overview of Cost-Effectiveness 

Harrell Chesson, PhD 

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention 

Dr. Chesson presented summaries of three models of 9vHPV in US, as well as the impact and 

cost-effectiveness of 9vHPV vaccination versus 4vHPV vaccination. The three US models of 

9vHPV are as follows: 

 US HPV-ADVISE model (Brisson et al.) 

Based on published, 18-type Canadian model 

 Merck Model (Weiss, Pillsbury, Dasbach) 

Based on published 4vHPV model 

 Simplified Model (Chesson et al.) 

Based on published 4vHPV model 

During the October 2014 ACIP meeting, there was a presentation of the US HPV-ADVISE 

model based on a published 18-HPV type Canadian model, which has been fitted to US data. 

The Merck Model and the Simplified Model are based on former models that have been 

expanded to include the additional types of the 9-valent vaccine. All three of the 9vHPV models 

are dynamic, meaning that herd effects were included in the results. A wide range of health 

outcomes were also included: Cervical pre-cancers and cancer; other HPV-associated cancers 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

(e.g., anal, vaginal, vulvar, penile, oropharyngeal); genital warts; and recurrent respiratory 

papillomatosis (RRP), with the exception that the HPV-ADVISE model does not include RRP. 

In the interest of time, Dr. Chesson did not discuss all of these characteristics. In terms of the 

degree of complexity and comprehensiveness, the HPV-ADVISE Model ranks the highest. The 

Simplified Model ranks the lowest, and the Merck Model falls in between the two. All of the 

models assumed high efficacy for the 9vHPV and 4vHPV vaccines, a lifetime of protection, and 

the same cost assumptions (e.g., 9vHPV was assumed to cost $13 more per dose than the 

4vHPV vaccine). 

Based on data from Jemal and Saraiya, Dr. Brisson’s October 2014 ACIP presentation 

regarding the potential for additional cancer prevention in the US, the greatest gain from the 

9vHPV vaccine is in terms of cervical cancer prevention [Jemal JNCI 2013; Saraiya, JNCI 

(under review)]. Regarding the estimated effectiveness of the 4vHPV and 9vHPV vaccines in a 

scenario in which no cross-protection is assumed for vaccine administered to boys and girls, 

there is a 65% reduction in cervical cancer in the long-term with the 4vHPV vaccine. If both 

sexes were switched to 9vHPV vaccine, there would be an additional 14 percentage point 

decrease in cervical cancer. If cross-protection for the 4vHPV vaccine is assumed, the 4vHPV 

vaccine would have a greater impact and the marginal impact of the 9vHPV vaccine would be 

reduced. In terms of sex-specific 9vHPV vaccine strategies and the outcomes of cervical 

intraepithelial neoplasia (CIN) 2/3 and cervical cancer, the majority of the benefit is achieved 

through switching females to the 9vHPV vaccine. 

Regarding the cost-effectiveness results from the HPV-ADVISE model, under the scenario of no 

cross-protection for 4vHPV vaccine, 9vHPV vaccination for females and 4vHPV vaccine for 

males compared to a strategy of 4vHPV vaccine for both sexes shows the incremental costeffectiveness of switching females from the 4vHPV vaccine to the 9vHPV vaccine and indicates 

that this is cost-saving. This suggests that the additional costs of the 9vHPV vaccine are offset 

by the averted medical costs due to the additional benefits of the 9vHPV vaccine. The 

comparison of the strategy of 9vHPV vaccine for both sexes compared to the strategy of 

9vHPV vaccine for females and 4vHPV vaccine for males shows that the incremental costeffectiveness of switching males from 4vHPV to 9vHPV vaccine would be $31,000 per quality 

adjusted life year (QALY). In a scenario in which both sexes are switched from 4vHPV to 

9vHPV vaccine, the cost per QALY would be less than zero or cost-saving. The WG believes 

that this is the most applicable scenario to the current decision facing ACIP, given that sexspecific vaccine strategies are not likely to be a viable policy alternative in the US. 

In terms of the bottom line, all three models suggest that a scenario in which no cross-protection 

is assumed for the 4vHPV, switching from 4vHPV to 9vHPV likely would be cost-saving. When 

cross-protection is assumed for the 4vHPV vaccine, the results are similar across all models in 

that the cost per QALY gained by 9vHPV vaccination would be low. This strategy remains costsaving in the HPV-ADVISE Model, and is only $8,000 per QALY in the Simplified Model. The 

results were consistent in a range of sensitivity analyses when 9vHPV vaccine was compared to 

4vHPV vaccine for both sexes. The mean cost per QALY gained was less than $0 in most 

scenarios examined. The two exceptions were when 4vHPV cross-protection was assumed, in 

which the cost per QALY was $4,600 in the high coverage scenario and $6,600 in the low health 

care cost scenario. With respect to the uncertainty intervals generated in the analyses, the cost 

per QALY gained by the 9vHPV vaccine remained less than $10,000 when assuming no crossprotection for the 4vHPV vaccine and less than $25,000 when assuming cross protection for the 

4vHPV vaccine. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

In conclusion, the current 4vHPV program is expected to reduce HPV-related diseases 

substantially in the US. Switching to a 9vHPV program is expected to further reduce precancerous lesions and cervical cancer. The HPV-ADVISE model suggested additional 

reductions of 19% and 14% reduction in CIN2/3 and cervical cancer, respectively, with perhaps 

more modest reductions in the other HPV-associated cancers. Providing 9vHPV vaccine for 

girls provides the great majority of benefits of providing 9vHPV vaccination to both sexes. 

Primary 9vHPV vaccine for both sexes is likely cost-saving compared to 4vHPV vaccine for both 

sexes. Again, these results are consistent not only across the three models, but also within 

each model as the assumptions are varied. The cost per QALY gained by 9vHPV did not 

exceed $25,000 in the sensitivity analyses, and was less than zero in most of the scenarios 

examined. Analyses of additional 9vHPV for prior 3-dose 4vHPV vaccine recipients is 

underway; however, preliminary results are highly variable because of the incremental health 

benefit in terms of the gain per person vaccinated is quite small. 

Proposed Recommendations for Use of 9vHPV Vaccine 

Lauri Markowitz, MD 

HPV Vaccine Working Group 

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention 

Dr. Markowitz mentioned with regard to Dr. Chesson’s last point, that the provision of 9vHPV 

vaccine to individuals who have already received 4vHPV vaccine is an ongoing consideration 

for which additional modeling is being done. Given the time constraints due to the short ACIP 

meeting, it was not possible to address this issue adequately during this session. 

For the 9vHPV vaccine recommendations, the plan is to publish an MMWR Policy Note. These 

are shorter than a full ACIP statement. There will be a link to the GRADE tables on the ACIP 

website. Specific sections Dr. Markowitz highlighted for discussion during this session included 

the following: 

 Routine recommendations 

 Administration/intervals 

 Interchangeability 

 Vaccine pregnancy registry 

 Future policy issues 

For each, she briefly reviewed some considerations discussed by the WG and then presented 

the draft wording to be included in the Policy Note. 

For routine recommendations and age groups, the WG proposed the same age groups as in the 

current recommendations. 9vHPV use in males older than age 15 years would be off-label at 

present and was discussed previously with ACIP. Immunogenicity data in males 16 through 26 

years were presented to ACIP in October 2014, included in GRADE, and were submitted to the 

FDA. Compared with 4vHPV, 9vHPV would provide little additional benefit for males. However, 

programmatic issues were considered for male recommendations, including the low likelihood 

that providers would stock two different HPV vaccines and the fact that there eventually will be a 

transition from 4vHPV to 9vHPV vaccine. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

The proposed routine recommendation follows, with new wording underlined: 

“ACIP recommends routine HPV vaccination at age 11 or 12 years. The vaccination 

series can be started beginning at age 9 years. Vaccination is also recommended for 

females aged 13 through 26 years and for males aged 13 through 21 years who have 

not been vaccinated previously or who have not completed the 3-dose series. Males 

aged 22 through 26 years may be vaccinated.* Vaccination of females is recommended 

with 2vHPV, 4vHPV (as long as this formulation is available), or 9vHPV. Vaccination of 

males is recommended with 4vHPV (as long as this formulation is available) or 9vHPV.” 

*Recommendation for men who have sex with men and for immunocompromised 

persons (including those with HIV infection) are also included in “Special Populations”: 

“Vaccination is also recommended for men who have sex with men or for 

immunocompromised persons (including those with HIV infection) aged 22 through 26 

years, if not vaccinated previously.” 

“2vHPV, 4vHPV and 9vHPV all protect against HPV 16 and 18, types that cause about 

66% of cervical cancers and the majority of other HPV-attributable cancers in the United 

States. 9vHPV targets five additional cancer causing types, which account for about 

15% of cervical cancers. 4vHPV and 9vHPV also protect against HPV 6 and 11, types 

that cause genital warts.” 

There will be a link to the GRADE tables in the recommendations. The proposed wording does 

not specifically state a preference for any vaccine, but outlines the differences between the 

vaccines and what they can protect against. 

The current wording in the section on administration addressing intervals is, “The second dose 

should be administered 1–2 months after the first dose and the third dose 6 months after the 

first dose.” Of note is that studies of 4vHPV and 2vHPV vaccine show that longer intervals 

between doses do not result in lower antibody titers, and some studies found higher titers after 

longer intervals. The WG discussed the value of mentioning flexibility in schedules. The pros 

and cons of this were discussed. Some WG members felt this was important to mention. 

Others were concerned about possible confusion for vaccination providers. The compromise 

was to allow flexibility by changing some of the wording. Also of note is that the intervals on the 

schedule will remain the same at 0, 1-2, and 6 months. The proposed wording for 

administration follows: 

“2vHPV, 4vHPV and 9vHPV are each administered in a 3-dose schedule. The second 

dose should be is administered at least 1 to 2 months after the first dose, and the third 

dose at least 6 months after the first dose. If the vaccine schedule is interrupted, for 

either HPV4 or HPV2, the vaccination series does not need to be restarted.” 

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There have been no studies of the interchangeability of HPV vaccines. However, there are 

some data on 9vHPV vaccine after three doses of 4vHPV vaccine from a study conducted as 

part of the 9vHPV vaccine clinical program. The WG discussed programmatic issues related to 

transition to the 9vHPV vaccine for consideration of wording. Again, the cross-outs and 

underlines show items to remove and add: 

“ACIP recommends that the HPV vaccination series for females be completed with the 

same HPV vaccine product, whenever possible. However, If vaccination providers do not 

know or do not have available the HPV vaccine product previously administered, or are 

in settings transitioning to 9vHPV, for protection against HPV 16 and 18 either any HPV 

vaccine product may be used to continue or complete the series for females; to provide 

protection against HPV 16 and HPV 18. Only HPV4 is licensed for use in males 4vHPV 

or 9vHPV may be used to continue or complete the series for males.” 

No changes were proposed to the recommendations for vaccination during pregnancy. This 

section is being updated to reflect new information on vaccine in pregnancy registries. A 

pregnancy registry has been established for 9vHPV. Also of note is that the bivalent vaccine 

pregnancy registry was closed earlier this month with concurrence from FDA. Wording will be 

added about the 9vHPV vaccine and a note will be made that the quadrivalent and bivalent 

vaccine registries have been closed. The proposed pregnancy recommendation follows: 

“Patients and health care providers can report an exposure to HPV vaccine during 

pregnancy to Vaccine Adverse Event Reporting System (VAERS). A new registry has 

been established for 9vHPV. Pregnancy registries for 4vHPV and 2vHPV have been 

closed with concurrence from FDA. Exposure during pregnancy should be reported to 

the respective manufacturer.” 

The last issue for which there was discussion in the WG was Future Policy Issues, a short 

section proposed at the end of the Policy Note. The discussion centered on what should be 

included in the policy note specifically related to the ongoing trial of a 2-dose schedule with 9­

valent HPV vaccine. Some WG members were concerned about confusion for providers, which 

could lead to delay in vaccination. However, the WG came to a compromise for the proposed 

wording for this section which follows: 

“A clinical trial is ongoing to assess alternate dosing schedules of 9vHPV. ACIP will 

formally review the results as data become available. HPV vaccination should not be 

delayed pending availability of 9vHPV or of future clinical trial data.” 

Though not under consideration during this session, the WG is discussing 9vHPV vaccine for 

persons who previously completed an HPV vaccination series. It is important to note that the 

manufacturer did not seek an indication for 9vHPV vaccine in persons who previously 

completed an HPV vaccination series. However, a study was conducted that evaluated 9vHPV 

vaccine in prior 4vHPV vaccinees (Protocol 006) and the data are included in the label. Due to 

the time constraints of this session, these data will be presented during the June 2015 ACIP 

meeting. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Discussion Points 

Ms. Pellegrini thanked the WG for the revised language on administration. She thought it would 

be very helpful in parent education to be able to say that the series does not have to be 

completed within a very restrictive timeframe for teens. Regarding interchangeability, it seemed 

like there was an implicit recommendation not to use bivalent vaccine and that 4vHPV or 9vHPV 

vaccine should be used to complete a series. 

Dr. Markowitz replied that for females, the goal was to convey that any vaccine could be used to 

continue or complete a series. Since only one vaccine was approved and recommended for 

males last time, there was not a separate statement for males. There are now separate 

statements. 

Ms. Pellegrini indicated that she would communicate further with the WG offline. 

Dr. Harriman said the same language indicated to him that if a provider has 4vHPV vaccine and 

that is what someone began with, it would be preferred. 

Dr. Markowitz indicated that they tried to soften the language by removing the first sentence, 

because it suggested that ACIP recommends that the vaccination series for females should be 

completed with the same product whenever possible. They wanted to liberalize this, 

acknowledging what would eventually occur with the transition. 

Dr. Harriman pointed out that if there was not a preference to use 4vHPV if that was already 

started, it seemed like the language used for males could be used. 

Dr. Markowitz said the WG tried to make the language the same for males and females. The 

only difference is the vaccines that are recommended for males and females. She asked 

whether part of the language should address vaccine providers who do not know the previous 

vaccines given, do not have 4vHPV vaccine available, or are transitioning to 9vHPV. 

Dr. Harrison suggested that it read, “If the vaccine series has already been started, either 

vaccine can be used to complete the series” rather than “if you do not have 4vHPV.” 

Dr. Markowitz emphasized that the sentence was meant to apply to both males and females, 

and was not meant to read that way just for females. 

Dr. Bennett pointed out that a provider could still be giving the bivalent vaccine for females; 

whereas, for males that would not be indicated. 

Dr. Temte requested a reminder about the current percentage of 4vHPV vaccine being used in 

the US. 

Dr. Markowitz replied that probably over 98% of vaccine being used is 4vHPV, so the 

recommendation is geared toward people who are giving quadrivalent vaccine. 

Dr. Temte noted that in essence, the WG was being very inclusive but was also acknowledging 

reality, which he thought was nicely conveyed. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Sawyer pointed out that the statement that some studies have demonstrated higher titers 

with longer intervals will invite providers to ask how much longer. He asked how this would be 

addressed in the Policy Note. 

Dr. Markowitz replied that some clarification could be added about this. There is limited room in 

the Policy Note, so it does not contain that level of detail. Perhaps some language could be 

added. 

Dr. Sawyer thought that language should be added to put a boundary around the intervals in 

terms of what the data show. Then providers can decide. 

Dr. Lett asked whether any language would appear in the Policy Note about the data pertaining 

to revaccination even though this information was not presented during this session. 

Dr. Markowitz thought they could ask the ACIP members how they felt about this. The ACIP 

has not been able to discuss this, so they could be silent on that matter or could indicate some 

place in the Policy Note that this will be discussed in the future. 

Dr. Schuchat indicated that this is an issue that ACIP has not been able to deliberate, so there 

are other ways that CDC can make some factual information available to clinicians pending 

ACIP deliberating on what they would like to say about the matter. 

Dr. Temte stressed that because this will be addressed during the June 2015 meeting, he was 

not uncomfortable having a four-month window, especially in terms of an off-label use for a new 

product with which people are just becoming familiar . 

Dr. Harrison requested clarity about whether there would be a vote in June or just an informal 

session about those previously vaccinated with quadrivalent vaccine. 

Dr. Markowitz assumed they would be anticipating a vote on the wording if ACIP wanted that 

included in a Policy Note. 

Dr. Harrison wondered whether consideration should be given to an informational session 

before the next meeting regarding this and the MenB issue. In the past, the members have had 

some difficulty being presented with a recommendation that addresses information that is not 

straightforward, or making decision on the spot and trying to take a vote during the same 

meeting. 

Dr. Schuchat indicated that it would not be possible to convene an informational session prior to 

the June meeting. 

Dr. Markowitz added that information could be provided to members as background materials 

before the June meeting, which would probably offer enough information for the members to be 

able to address this. 

Dr. Middleman (SAHM) asked whether it might be helpful to add a statement about efficacy 

being known only if the series is completed in order to ensure that completion is the end game. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Dr. Markowitz suggested that one other way that might avoid confusion would be to eliminate 

the sentence entirely which states that “some studies have found” and just say that “the second 

dose should be administered at least one to two months later, and the third dose at least six 

months later.” Others agreed that this would be a good idea. Dr. Markowitz pointed out that 

this does not differ from the current recommendations stating that if the vaccination schedule is 

interrupted, it does not need to be restarted. This was just to clarify by highlighting the intervals. 

Vote: HPV Package 

Dr. Rubin made a motion to approve the package of HPV vaccine recommendations, with 

deletion of the sentence pertaining to antibody levels being higher with longer intervals between 

doses. Dr. Vazquez seconded the motion. The motion carried with 14 affirmative votes, 0 

negative votes, and 1 abstention. The disposition of the vote was as follows: 

14 Favored: Bennett, Belongia, Bocchini, Campos-Outcalt, Harriman, Harrison, Karron, 

Kempe, Pellegrini, Romero, Riley, Rubin, Temte, and Vazquez 

0 Opposed: N/A 

1 Abstained: Reingold 

Dr. Fryhofer (ACP) acknowledged the time constraints of the current meeting, but emphasized 

that the question regarding revaccination with 9vHPV of patients who received 4vHPV is raised 

by many practitioners. ACP looks forward to guidance from ACIP and in getting the word out 

about what should be done. 

Dr. Neuzil (IDSA) thought one of the most common questions following publication of the new 

recommendations would relate to the timeline of the availability of 9vHPV vaccine. Therefore, it 

would be helpful if someone could comment on that before the end of the session. 

Julie McCafferty (Merck) indicated that Merck has 9vHPV vaccine currently available, as well as 

a continued supply of Gardasil®. They are also waiting for greater commercial coverage from an 

insurance perspective for 9vHPV vaccine to be more broadly available in the US. 

Vaccines for Children 

Dr. Jeanne M. Santoli 

Immunization Services Division 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention 

Dr. Santoli explained that the purpose of this presentation was to update the resolution to 

include use of a 9vHPV vaccine that was recently licensed for use and to clarify the schedule 

and timing of vaccine intervals. The recommendations proposed follow. 

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– 

–	 

 

 

Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Eligible Groups: 

Gender and Age Bivalent 

HPV Vaccine 

Quadrivalent 

HPV Vaccine 

9-Valent HPV 

Vaccine 

Females, 9 

through 18 years 

Eligible Eligible Eligible 

Males, 9 through 

18 years 

Not eligible Eligible Eligible 

Recommended Schedule and Interval: 

 ACIP recommends routine HPV vaccination at age 11 or 12 years. Eligible females and 

males as young as 9 years old may be vaccinated. Vaccination is recommended for 

females and males 13 through 18 years of age who have not been previously vaccinated or 

who have not completed the full series. 

 HPV2, HPV4 and HPV9 are each administered in a 3-dose schedule. The second dose is 

administered at least 1 to 2 months after the first dose and the third dose at least 6 months 

after the first dose. 

 If vaccination providers do not know, or do not have available the HPV vaccine product 

previously administered, or are in clinical settings transitioning to HPV9, for protection 

against HPV 16 and 18, any available HPV vaccine product may be used to continue or 

complete the series for females; HPV9 or HPV4 may be used to continue or complete the 

series for males. 

 If the vaccine schedule is interrupted, the vaccine series does not need to be restarted. The 

first and second doses should be separated by an interval of least four weeks. The second 

and third doses should be separated by an interval of at least 12 weeks, with a minimum 

interval of 24 weeks between the first and third doses. 

Recommended Dosage and Contraindications/Precautions: 

 Recommended dosage 

Refer to product package inserts. 

 Contraindications and Precautions 

Contraindications and Precautions can be found in the package inserts available 

at 

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM09 

3833 

Statement Regarding Update Based on Published Documents 

[If an ACIP recommendation regarding HPV vaccination is published within 12 months following 

this resolution, the relevant language above (except in the eligible groups sections) will be 

replaced with the language in the recommendation and incorporated by reference to the 

publication URL.] 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Discussion Points 

Dr. Harriman suggested that it would be valuable to use the exact same language from the 

Policy Note in the VFC recommendation in terms of weeks and months. 

Dr. Markowitz noted that some of the minimal intervals historically have been in weeks, which 

relates to registries and how they are used. The minimal intervals do mirror each other, which 

she did not show because these have not changed. 

Dr. Temte pointed out that forecasting for systems needs a specific numbers of days, which 

cannot be done with months because the number of days in a month can vary. As long as it is 

consistent with other VFC resolutions, he thought they could let it stand. 

Dr. Harriman emphasized that it would be nice for the language to be harmonized throughout. 

Perhaps it needs to go in the other direction—the Policy Note should mirror the VFC. 

Dr. Schuchat indicated that the readers of the VFC are not the same. Obviously, there is 

strengthening of the quality when there is harmonization, so they will take this back. 

Vote: VFC for HPV 

Dr. Kempe made a motion to approve the VFC recommendations for HPV vaccination. Dr. 

Romero seconded the motion. The motion carried with 14 affirmative votes, 0 negative votes, 

and 1 abstention. The disposition of the vote was as follows: 

14 Favored: Bennett, Belongia, Bocchini, Campos-Outcalt, Harriman, Harrison, Karron, 

Kempe, Pellegrini, Romero, Riley, Rubin, Temte, and Vazquez 

0 Opposed: N/A 

1 Abstained: Reingold 

Yellow Fever Vaccine 

Introduction 

Joseph A. Bocchini, Jr, MD 

ACIP, Workgroup Chair

Japanese Encephalitis (JE) and YF (YF) Vaccines WG

Professor and Chairman, Department of Pediatrics 

Louisiana State University Health Sciences Center 

Dr. Bocchini indicated that during this session, the Japanese Encephalitis (JE) and Yellow Fever 

(YF) Vaccines WG would present follow-up information related to YF vaccine in anticipation of 

an ACIP vote. He thanked the members of the WG for their participation, especially Dr. Erin 

Staples for her work as the CDC lead for this WG. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

As a reminder, WHO’s Strategic Advisory Group of Experts (SAGE) concluded in April 2013 that 

a single dose of YF vaccine is sufficient to confer lifelong protection and that booster doses 

were no longer needed. Additional data, however, were indicated by the WHO for identifying 

specific risk groups who might benefit from a second dose or a booster dose. Since 1965, 

International Health Regulations (IHRs) have allowed countries to require a YF vaccine dose 

within the past 10 years for entry. In June 2014, the WHO’s World Health Assembly (WHA) 

adopted an amendment to the IHR that extends YF vaccine protection to the life of the person 

vaccinated. That change will take effect in June 2016, so there will no longer be a requirement 

for countries to maintain that 10-year interval. 

Because of those changes, the JE Vaccine WG was re-formed to include YF vaccine in October 

2013. The WG met multiple times to discuss the booster doses. ACIP has heard three 

previous presentations on this topic, including a presentation of GRADE. In June 2014, the WG 

presented the initial set of recommendations. Subsequently, feedback was received from ACIP 

and the WG continued to meet to address the issues raised by the members. During the June 

meeting, there was general support to remove the booster dose requirement, but questions 

were raised about groups for whom additional doses would be considered. There was 

discussion regarding the immune response in children, the interval between doses in certain 

groups, and what constitutes high-risk settings for exposure to YF. 

With respect to the issue related to children, the WG worked with AAP’s COID. A presentation 

was made during COID’s November 2014 meeting. An updated analysis on immune response 

for children and whether children’s immune response to YF vaccine differed from adults were 

discussed. The WG also discussed the time interval for additional doses in pregnant women, 

hematopoietic stem cell transplant recipients, HIV-infected individuals, and high-risk settings for 

exposure to wild-type YF virus. 

During this session, Dr. Staples presented a summary of the GRADE review, considerations for 

special populations, and proposed recommendations for consideration and a vote by ACIP. 

GRADE Summary for YF Booster Doses, Consideration of 

Booster Doses in Specific Populations, and Proposed Recommendations 

J. Erin Staples, MD, PhD 

Arboviral Diseases Branch 

Division of Vector-Borne Diseases 

Centers for Disease Control and Prevention 

Dr. Staples reminded everyone that the primary policy question the WG studied for GRADE 

was, “Should booster doses of YF vaccine every 10 years continue to be recommended for 

healthy travelers and laboratory workers?” The intervention would be to remove the current 

recommendation for booster doses. The current option is to continue the current 

recommendation for booster doses of YF vaccine. 

In terms of the outcome measures the WG assessed for YF vaccine booster doses in the 

GRADE evaluation, the benefits included vaccine efficacy, seroprotection, vaccine 

effectiveness, and seropositivity. However, there are no data on vaccine efficacy or 

seroprotection. The three harms the WG considered to be critical included SAEs, viscerotropic 

disease, and neurologic disease. Dr. Staples reviewed the main findings for each critical 

outcome. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Vaccine effectiveness was defined as a lack of vaccine failures. Among over 540 million doses 

of YF vaccine administered, 18 vaccine failures have been identified. Only 2 (11%) of the 18 

vaccine failures occurred more than 10 years from the last dose of vaccine at 20 and 27 years. 

Regarding seropositivity data at ≥10 years following YF vaccination, there were 13 

observational studies with immunogenicity data for 1137 persons. The estimate of seropositivity 

is 92% (95%CI 85%-96%) using a random effects model. There were three observational 

studies with immunogenicity data for 164 people ≥20 years post-vaccination. The estimate for 

seropositivity for this group is 80% (95% CI 74%-86%) random effects model. 

Moving to the harms, there were nine observational studies that had data on 333 million doses 

of the vaccine distributed. There were 1255 subjects who reported SAEs following vaccination. 

Of the 201 subjects for whom the dose type was known, 7% occurred following a booster dose 

of YF vaccine. The data were similar for YF vaccine-associated viscerotropic and neurologic 

disease. 

As a reminder, the initial evidence types used for GRADE are as follows (with 1 being the 

highest level of confidence in the estimated effects on the outcomes and 4 being the lowest): 

1 Randomized control trials (RCTs) or overwhelming evidence from observational 

studies 

2 RCTs with important limitations or exceptionally strong evidence from observational 

studies 

3 Observational studies or RCTs with notable limitations 

4 Clinical experience, observational studies with important limitations, or RCTs with 

several major limitations 

The quality of evidence for each of the five critical outcomes assessed for YF vaccine booster 

doses was 4, given that only observational studies were included. All of the observational 

studies had important limitations specifically related to bias and indirectness. The overall quality 

of evidence was 4. 

An additional policy question was created to address persons who were considered by the WG 

not to belong to healthy travelers and laboratory workers, which was “Should booster doses of 

YF vaccine every 10 years continue to be recommended for travelers and laboratory workers 

who had a precaution to vaccination that might have negatively impacted their immune 

response to their primary dose of YF vaccine (e.g., pregnancy, asymptomatic HIV infection, or 

age 6 through 8 months)? 

Two observational studies provided immunogenicity data for pregnant women following YF 

vaccination. In the first study, 39% (32/83) of pregnant women vaccinated during their third 

trimester seroconverted. This is in comparison to 94% (89/95) of the general population who 

received the vaccine at the same time in Nigeria as part of an outbreak response. In a second 

study conducted in Brazil, 98% (425/433) of pregnant women vaccinated primarily during their 

first trimester seroconverted and developed YF virus-specific antibodies. From these two 

studies, the conclusion can be drawn that the proportion of pregnant women who develop 

antibody titers following YF vaccination is variable, but data indicate a lack of initial 

seroconversion for some pregnant women. Given this, the WG suggests revaccinating women 

who receive their initial dose of YF vaccine while pregnant one time prior to their next at-risk 

travel. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

There are no immunogenicity data for YF vaccine in hematopoietic stem cell (HSCT) recipients. 

However, the data suggests that most recipients become seronegative to live viral vaccine 

antigens post-transplantation. The Infectious Disease Society of America (IDSA) guidelines 

currently recommend re-administering live viral vaccines, specifically measles, mumps, rubella 

(MMR) and varicella vaccines post-transplant when the recipient is no longer 

immunosuppressed. Given this, the WG suggested revaccinating HSCT recipients one time 

prior to their next at-risk travel as long as they are immunocompetent. 

Three studies compared the immunogenicity of YF vaccine in HIV-infected persons to 

uninfected persons. In the first study, 17% (3/18) of HIV-infected children had YF virus-specific 

antibodies on average 10 months post-vaccination. This is in comparison to 74% (42/57) in age 

and nutritionally matched children. In the second study, 83% (65/78) of HIV-infected travelers 

had YF virus-specific antibodies one year post-vaccination in comparison to 97% (64/66) of 

uninfected controls. In the third study, 77% (54/70) of HIV-infected travelers had YF virusspecific antibodies at 1 to 10 years post-vaccination in comparison to 88% (81/92) of uninfected 

controls. To summarize, the data indicate that HIV-infected persons are less likely to have 

sustained YF virus-specific antibody titers following vaccination. Given this, the WG suggested 

continuing doses of YF vaccine every 10 years for persons who received YF vaccine while 

infected with HIV. 

A specific area of discussion following the June 2014 ACIP meeting was young children. There 

were 12 studies with immunogenicity data on 4675 children aged 4 months to 10 years in 

endemic areas at least 1 to 2 months post-vaccination. The estimated seroconversion rate is 

93% (88%-96%) using a random effects model. Differences in seroconversion rates were 

compared among different pediatric age groups. Because the studies often aggregated their 

results by age, there were two age groups that could be readily explored. The seroconversion 

rates for children aged ≥9 months compared to children aged <9 months were 92% (95% CI 

86%-96%) and 95% (95% CI 91%-98%), respectfully. The seroconversion rates for children 

aged ≥12 months compared to children aged <12 months were 89% (95% CI 78%-96%) and 

93% (95% CI 87%-97%), respectfully. To summarize the pediatric data and note other 

considerations, the estimated pediatric seroconversion rate was 93% (95% CI 88-96%). The 

unadjusted seroconversion rate for adults at the same time point is 98% percent for all 

populations and 97% for endemic populations. As a reminder, the pediatric data were only from 

endemic areas. Based on available data, there are no clear age differences in seroconversion 

rates. When these data were presented and discussed with the AAP’s COID, they concluded 

that young children were not immunologically different from adults in their response to YF 

vaccine. 

The WG also considered persons thought to be at higher risk for YF virus exposure based on 

season, location, activities, and duration of their exposure. The situations in which persons are 

considered to be at risk for YF virus exposure include West Africa during peak transmission 

season, where the disease risk is estimated to be approximately 10 times higher than South 

America; areas with ongoing outbreaks; laboratory settings with regular exposure to wild-type 

YF virus; and travel for long periods of time (e.g., months to years). 

To summarize YF vaccine booster dose data and considerations, very few vaccine failures were 

noted following YF vaccine. Most (92%) vaccine recipients are seropositive at ≥10 years postvaccination. SAEs are uncommon following booster doses of YF vaccine. High value is placed 

on preventing a serious disease with no treatment and poor outcome. The current statement in 

the ACIP recommendations will no longer be relevant when the IHR is updated in June 2016. 

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Advisory Committee on Immunization Practices (ACIP)	 Summary Report February 26, 2015 

Based on the available data, the WG concluded that a single dose of YF vaccine provides longlasting protection in most travelers. Therefore, the WG would no longer recommend booster 

doses of YF vaccine for most travelers. YF vaccine booster doses should be recommended for 

persons whose immune response to a previous dose might have been compromised. 

Consideration should be given to YF vaccine booster doses for persons in higher-risk settings 

for exposure to YF virus. With this in mind, the WG proposed the following recommendations 

for ACIP’s consideration and vote: 

For Most Travelers 

“A single dose of yellow fever vaccine provides long-lasting protection and is adequate 

for most travelers.” (Recommendation category A) 

Recommendations for Certain Populations 

“Additional doses of yellow fever vaccine are recommended for certain travelers, 

including: 

 Women pregnant when they received their initial dose of yellow fever vaccine

should receive one additional dose of yellow fever vaccine prior to their next

travel that puts them at risk for yellow fever virus infection.

 Individuals who received a hematopoietic stem cell transplant after receiving a

dose of YF vaccine and who are sufficiently immunocompetent to be safely

vaccinated should be revaccinated prior to their next travel that puts them at risk

for yellow fever virus infection.

 Individuals who were HIV-infected when they received their last dose of yellow

fever vaccine should receive a dose every 10 years if they continue to be at risk

for yellow fever virus infection.

Persons being considered for additional doses of yellow fever vaccine should be 

assessed for contraindications or precautions.” (Recommendation category A) 

Recommendations for High-Risk Settings 

“A booster dose may be considered for travelers who received their last dose of YF 

vaccine at least 10 years previously and who will be in a higher-risk setting based on 

season, location, activities, and duration of their travel. This would include travelers who 

plan to spend a prolonged period of time in endemic areas or those traveling to highly 

endemic areas such as rural West Africa during peak transmission season or areas with 

ongoing outbreaks.” (Recommendation category B) 

Recommendation for Laboratory Workers 

“Laboratory workers who routinely handle wild-type yellow fever virus should have yellow 

fever virus-specific neutralizing antibody titers measured at least every 10 years to 

determine if they should receive additional doses of the vaccine. For laboratory workers 

who are unable to have neutralizing antibody titers measured, yellow fever vaccine 

should be given every 10 years as long as they remain at risk.” (Recommendation 

category A).

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Discussion Points 

Dr. Reingold inquired as to whether the rationale for recommending vaccination for all pregnant 

women was because it is unlikely that women will know the trimester in which they were 

vaccinated. 

Dr. Staples replied that the information was derived from only two studies, which is insufficient 

to conclude with certainty that the third trimester is the issue. The recommendation is more 

conservative in saying that if a woman is vaccinated during pregnancy, she should receive 

another dose if possible. 

Dr. Campos-Outcalt asked whether the option of antibody titers had been considered for groups 

under consideration for revaccination other than laboratory workers, given that there was some 

seroconversion among all of the groups, and given that AEs can occur with the vaccine. 

Dr. Staples indicated that the WG did discuss antibody titers. Currently, the only place that 

performs antibody titer testing is CDC’s Fort Collins facility. This is done with a plaque 

neutralization test, and the results take about four weeks. The travel practitioners in the WG did 

not think this would be very practical from a time and logistics perspectives. CDC traditionally 

does antibody testing for many of the high-risk groups of concern. That is already being done 

and could be maintained. The number of laboratory workers who handle wild-type YF virus on a 

regular basis is quite small, and they will be aware of and should be able to obtain neutralization 

testing. 

Ms. Pellegrini recalled that during the fall discussion regarding children, there was some 

question about whether travelers who were vaccinated as children would, indeed, have lifelong 

protection. She wondered whether the WG was able to find any data that would help clarify this. 

Dr. Staples responded that the WG reviewed the pediatric data, and she showed all of the data 

available for the initial seroconversion. There is only one study available and the data do not 

deal primarily with YF. Instead, the study assessed children who received YF vaccine because 

they were going to receive their chimeric dengue vaccine. The children in this study were 

assessed based on age cohorts. Given that some of them had been revaccinated, the results 

are confusing and unhelpful. The AAP agreed that additional data would be beneficial, and this 

is one of the studies that the WG has highlighted for future work. 

Dr. William Atkinson indicated that he was posing a question on behalf of Dr. Stanley Plotkin, 

who was unable to attend due to the Southern snowstorm. Dr. Plotkin’s inquiry pertained to the 

study recently published in Vaccine showing 17% seronegative 5 to 9 years in normal 

individuals. 

Dr. Staples replied that she would have to review the specific data to which Dr. Plotkin was 

referring, given that several YF vaccine studies had been published in Vaccine in the last six 

months. The WG has also been grappling with what actually constitutes “seroprotection,” 

because different assays and different cutoffs are used to represent what would be detectable 

antibodies. Therefore, it would be difficult to comment on the results of a particular study 

without seeing those types of details. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Vote: YF Vaccine Booster Dose 

Dr. Rubin made a motion to approve the recommendations for a Yellow Fever vaccine booster 

dose. Dr. Belongia seconded the motion. The motion carried with 15 affirmative votes, 0 

negative votes, and 0 abstentions. The disposition of the vote was as follows: 

15 Favored: Bennett, Bocchini, Belongia, Campos-Outcalt, Harriman, Harrison, Karron, 

Kempe, Pellegrini, Romero, Reingold, Riley, Rubin, Temte, and Vazquez 

0 Opposed: N/A 

0 Abstained: N/A 

Public Comment 

No public comments were offered during this specific session. Given that all public comments 

presented during this meeting pertained to meningococcal vaccine, they are included within the 

meningococcal section of this document. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Certification 

Upon reviewing the foregoing version of the February 26, 2015 ACIP meeting minutes, Dr. 

Jonathan Temte, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC. 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

ACIP Membership Roster 

CHAIR 

TEMTE, Jonathan L., MD, PhD 

Professor of Family Medicine 

University of Wisconsin School of Medicine and Public Health 

Madison, WI 

Term: 07/01/2011-06/30/2015 

EXECUTIVE SECRETARY 

PICKERING, Larry K., MD 

Senior Advisor to the Director 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS 

BENNETT, Nancy, MD, MS 

Professor of Medicine and Community and Preventive Medicine 

University of Rochester School of Medicine and Dentistry 

Rochester, NY 

Term: 07/01/2011-06/30/2015 

BELONGIA, Edward, MD 

Director 

Center for Clinical Epidemiology & Population Health 

Marshfield Clinic Research Foundation 

Marshfield, WI 

Term: 07/01/2014-06/30/2018 

BOCCHINI, Joseph A., Jr., MD 

Professor and Chairman 

Department of Pediatrics 

Louisiana State University Health Sciences Center 

Shreveport, LA 

Term: 07/01/2011-06/30/2015 

CAMPOS-OUTCALT, Douglas, MD, MPA 

Medical Officer 

Mercy Care Plan 

Phoenix, AZ 

Term: 07/01/2011-06/30/2015 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

HARRIMAN, Kathleen, PhD, MPH, RN 

Chief, Vaccine Preventable Disease Epidemiology Section 

Immunization Branch 

California Department of Public Health 

Richmond, CA 

Term: 07/01/2012 – 06/30/2016 

HARRISON, Lee H., MD 

Professor of Medicine and Epidemiology 

Infectious Diseases Epidemiology Research Unit 

University of Pittsburgh 

Pittsburgh, PA 

Term: 07/01/2012 – 06/30/2016 

KARRON, Ruth A., MD 

Professor and Director 

Center for Immunization Research 

Department of International Health 

Johns Hopkins Bloomberg School of Public Health 

Baltimore, MD 

Term: 07/01/2012 – 06/30/2016 

KEMPE, Allison, MD, MPH 

Professor of Pediatrics 

Director of Primary Care Fellowship 

University of Colorado School of Medicine 

Director of Research 

Division of General Academic Pediatrics 

Director of Children’s Outcomes Research Program 

The Children’s Hospital of Denver 

Denver, CO 

Term: 07/01/2013 - 06/30/2017 

PELLEGRINI, Cynthia 

Senior Vice President 

Public Policy and Government Affairs 

March of Dimes 

Washington, DC 

Term: 07/01/2013-06/30/2017 

REINGOLD, Arthur L., MD 

Professor of Epidemiology 

Edward Penhoet Distinguished for Global Health and Infectious Disease 

Associate Dean for Research 

School of Public Health 

University of California 

Berkeley, CA 

Term: 07/01/2013-06/30/2017 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

RILEY, Laura E., MD 

Associate Professor, Obstetrics, Gynecology and Reproductive Medicine 

Harvard Medical School 

Maternal Fetal Medicine 

Massachusetts General Hospital 

Boston, MA 

Term: 07/01/2014-06/30/2018 

ROMERO, José R., MD, FAAP 

Professor of Pediatrics 

Horace C. Cabe Endowed Chair in Infectious Diseases 

Director, Pediatric Infectious Diseases Section 

University of Arkansas for Medical Sciences and 

Arkansas Children's Hospital 

Director, Clinical Trials Research 

Arkansas Children's Hospital Research Institute 

Little Rock, AR 

Term: 07/01/2014-06/30/2018 

RUBIN, Lorry, MD 

Director 

Pediatric Infectious Diseases 

Steven and Alexandra Cohen Children’s Medical Center of New York 

North Shore-Long Island Jewish Health System 

New Hyde Park, NY 

Professor of Pediatrics, Hofstra-North Shore LIJ School of Medicine 

Hempstead, NY 

Term: 07/01/2012 – 06/30/2016 

VÁZQUEZ, Marietta, MD 

Associate Professor of Pediatrics 

Department of Pediatrics 

Yale University School of Medicine 

New Haven, CT 

Term: 07/01/2011-06/30/2015 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS) 

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification 

Centers for Medicare and Medicaid Services 

Baltimore, MD 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Department of Defense (DoD) 

SERGIENKO, Eric, MD, MPH CAPT, Medical Corps, United States Navy Department of 

Defense Liaison Centers for Disease Control and Prevention Atlanta, GA 

Department of Veterans Affairs (DVA) 

KINSINGER, Linda S., MD, MPH 

Chief Consultant for Preventive Medicine 

Office of Patient Care Services 

National Center for Health Promotion and Disease Prevention 

Durham, North Carolina 

Food and Drug Administration (FDA) 

SUN, Wellington, MD 

Director, Division of Vaccines and Related Product Applications 

Office of Vaccines Research and Review 

Food and Drug Administration 

Rockville, MD 

Health Resources and Services Administration (HRSA) 

HOUSTON, A. Melissa, MD, MPH, FAAP 

Chief Medical Officer 

Division of Vaccine Injury Compensation 

Health Resources and Services Administration 

Rockville, MD 

Indian Health Service (IHS) 

GROOM, Amy, MPH 

Immunization Program Manager 

Indian Health Service 

Albuquerque, NM 

National Vaccine Program Office (NVPO) 

GELLIN, Bruce, MD, MPH 

Director 

National Vaccine Program Office 

Department of HHS, Public Health and Science 

Washington, DC 

National Institutes of Health (NIH) 

GORMAN, Richard L., MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases/NIAID 

National Institute of Health 

Bethesda, MD 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP) 

LOEHR, Jamie, MD, FAAFP 

Cayuga Family Medicine (Owner) 

Ithaca, NY 

American Academy of Pediatrics (AAP) 

BYINGTON, Carrie L., MD 

Chair, AAP Committee on Infectious Diseases 

H.A. and Edna Benning Presidential Professor of Pediatrics 

Associate Vice President for Faculty and Academic Affairs 

University of Utah Health Sciences Center 

Salt Lake City, UT 

American Academy of Pediatrics (AAP) 

KIMBERLIN, David, MD 

Red Book Editor 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine 

Birmingham, AL 

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

American College Health Association (ACHA) 

EVEN, Susan, MD 

Executive Director 

Student Health Center 

University of Missouri 

Columbia, MO 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Atlanta Perinatal Associates 

Atlanta, GA 

American College of Obstetricians and Gynecologists (ACOG) 

AULT, Kevin A., MD 

Professor and Division Director, General Obstetrics and Gynecology 

Department of Obstetrics and Gynecology 

Kansas City, KS 

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American College of Physicians (ACP) (alternate) 

 

Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

American College of Physicians (ACP) 

FRYHOFER, Sandra Adamson., MD, MACP 

Adjunct Associate Professor of Medicine 

Emory University School of Medicine 

Atlanta, GA 

POLAND, Gregory A., MD 

Mary Lowell Professor of Medicine and Infectious Diseases 

Mayo Clinic 

Rochester, MN 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics 

Geriatrics Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

NETOSKIE, Mark J., MD, MBA, FAAP 

Market Medical Executive, CIGNA 

Houston, TX 

American Medical Association (AMA) 

FRYHOFER, Sandra Adamson., MD, MACP 

Adjunct Associate Professor of Medicine 

Emory University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN, FAAOHN 

Assistant Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E., DO, FACOP 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

FOSTER, Stephan L., PharMD, FAPhA 

Professor and Vice Chair, Department of Clinical Pharmacy 

University of Tennessee Health Sciences Center, College of Pharmacy 

Memphis, TN 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Association of Immunization Managers (AIM) 

MOORE, Kelly, MD, MPH 

Medical Director, State Immunization Program 

Tennessee Department of Health 

Nashville, TN 

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W. Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences 

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

DWELLE, Terry L, MD, MPHTM, FAAP, CPH 

State Health Officer 

North Dakota Department of Health 

Bismarck, ND 

Biotechnology Industry Organization (BIO) 

LEWIN, Clement, PhD, MBA 

Head, Medical Affairs and Immunization Policy 

Novartis Vaccines and Diagnostics 

Cambridge, MA 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization 

Idaho Department of Health and Welfare 

Boise, ID 

Canadian National Advisory Committee on Immunization (NACI) 

GEMMILL, Ian MacDonald, MD, CCFP, FCFP, FRCP(C) 

Medical Officer of Health 

Kingston, Frontenac and Lennox & Addington Public Health 

Kingston, Ontario, Canada 

Department of Health, United Kingdom 

Vacant 

Infectious Diseases Society of America (IDSA) 

NEUZIL, Kathleen M., MD, MPH, FIDSA 

Vaccine Development Global Program (PATH) 

Clinical Professor 

Departments of Medicine and Global Health 

University of Washington School of Medicine 

Seattle, WA 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Infectious Diseases Society of America (IDSA) (alternate) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

National Association of County and City Health Officials (NACCHO) 

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A., RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Immunization Council and Child Health Program, Mexico

VILLASEÑOR RUIZ, Ignacio 

Directora del Programa de Atencion da la Salud de la Infancia y la Adolescencia / Director 

General, Child and Adolescent Health 

Centro Nacional Para la Salud de la Infancia Y La Adolescencia / National Center for Child and 

Adolescent Health 

Ministry of Health / Secretaría de Salud 

Mexico 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD 

Professor and Chair 

University of Medicine and Dentistry of New Jersey 

Robert Wood Johnson Medical School 

New Brunswick, NJ 

National Vaccine Advisory Committee (NVAC) 

ORENSTEIN, Walt, MD 

Chair, NVAC 

Associate Director, Emory Vaccine Center 

Emory University 

Atlanta, GA 

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Advisory Committee on Immunization Practices (ACIP) Summary Report February 26, 2015 

Pediatric Infectious Diseases Society (PIDS) 

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

Pediatric Infectious Diseases Society (PIDS) (alternate) 

ENGLUND, Janet A., MD 

Professor, Department of Pediatrics 

Seattle Children's Hospital 

University of Washington 

Seattle, WA 

Pharmaceutical Research and Manufacturers of America (PhRMA) 

BRAGA, Damian A. 

President, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B., MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center 

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA) 

WEBER, David, MD, MPH 

Professor of Medicine, Pediatrics, and Epidemiology 

University of North Carolina Schools of Medicine and Public Health 

Medical Director, Hospital Epidemiology and Occupational Health, UNC Health Care 

University of North Carolina 

Chapel Hill, NC 

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